510(k) Final Decisions Rendered since May 01, 2026

510(k) Final Decisions Rendered since May 01, 2026 U.S. Food and Drug Administration - Center for Devices and Radiological Health http://www.fda.gov/cdrh/510khome.html en-us Mon, 15 Jun 2026 05:33:05 GMT webo@cdrh.fda.gov http://www.fda.gov/graphics/mastheadart/centers/fda_mast_01.gif U.S. Food and Drug Administration - Center for Devices and Radiological Health http://www.fda.gov/cdrh/ Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers who must register to notify FDA, at least 90 days in advance, of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use. 116 70 510(k) No: K252543 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252543 Mon, 04 May 2026 04:00:00 GMT 510(k) No: K254115 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254115 Mon, 04 May 2026 04:00:00 GMT 510(k) No: K254019 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254019 Mon, 04 May 2026 04:00:00 GMT 510(k) No: K260716 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260716 Mon, 04 May 2026 04:00:00 GMT 510(k) No: K253251 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253251 Mon, 04 May 2026 04:00:00 GMT 510(k) No: K252954 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252954 Mon, 04 May 2026 04:00:00 GMT 510(k) No: K252622 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252622 Mon, 04 May 2026 04:00:00 GMT 510(k) No: K260256 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260256 Mon, 04 May 2026 04:00:00 GMT 510(k) No: K260688 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260688 Mon, 04 May 2026 04:00:00 GMT 510(k) No: K261132 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261132 Tue, 05 May 2026 04:00:00 GMT 510(k) No: K261130 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261130 Tue, 05 May 2026 04:00:00 GMT 510(k) No: K254202 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254202 Tue, 05 May 2026 04:00:00 GMT 510(k) No: K252558 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252558 Tue, 05 May 2026 04:00:00 GMT 510(k) No: K260742 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260742 Tue, 05 May 2026 04:00:00 GMT 510(k) No: K254200 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254200 Tue, 05 May 2026 04:00:00 GMT 510(k) No: K253152 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253152 Wed, 06 May 2026 04:00:00 GMT 510(k) No: K253855 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253855 Wed, 06 May 2026 04:00:00 GMT 510(k) No: K261112 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261112 Wed, 06 May 2026 04:00:00 GMT 510(k) No: K260747 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260747 Wed, 06 May 2026 04:00:00 GMT 510(k) No: K253027 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253027 Wed, 06 May 2026 04:00:00 GMT 510(k) No: K260376 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260376 Wed, 06 May 2026 04:00:00 GMT 510(k) No: K252552 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252552 Wed, 06 May 2026 04:00:00 GMT 510(k) No: K260775 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260775 Wed, 06 May 2026 04:00:00 GMT 510(k) No: K253647 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253647 Thu, 07 May 2026 04:00:00 GMT 510(k) No: K253826 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253826 Thu, 07 May 2026 04:00:00 GMT 510(k) No: K253739 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253739 Thu, 07 May 2026 04:00:00 GMT 510(k) No: K253837 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253837 Thu, 07 May 2026 04:00:00 GMT 510(k) No: K260460 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260460 Thu, 07 May 2026 04:00:00 GMT 510(k) No: K260974 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260974 Thu, 07 May 2026 04:00:00 GMT 510(k) No: K254276 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254276 Thu, 07 May 2026 04:00:00 GMT 510(k) No: K253992 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253992 Thu, 07 May 2026 04:00:00 GMT 510(k) No: K254183 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254183 Thu, 07 May 2026 04:00:00 GMT 510(k) No: K253396 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253396 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K254215 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254215 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K252621 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252621 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K253237 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253237 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K260419 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260419 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K252617 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252617 Fri, 08 May 2026 04:00:00 GMT 510(k) No: DEN250013 - Decision: Granted http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=DEN250013 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K253991 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253991 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K260321 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260321 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K260788 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260788 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K260792 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260792 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K253679 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253679 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K250814 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250814 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K253013 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253013 Fri, 08 May 2026 04:00:00 GMT 510(k) No: K261145 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261145 Sat, 09 May 2026 04:00:00 GMT 510(k) No: K260385 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260385 Sat, 09 May 2026 04:00:00 GMT 510(k) No: K254178 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254178 Mon, 11 May 2026 04:00:00 GMT 510(k) No: K260196 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260196 Mon, 11 May 2026 04:00:00 GMT 510(k) No: K260842 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260842 Mon, 11 May 2026 04:00:00 GMT 510(k) No: K250964 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250964 Mon, 11 May 2026 04:00:00 GMT 510(k) No: K254228 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254228 Mon, 11 May 2026 04:00:00 GMT 510(k) No: K252880 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252880 Mon, 11 May 2026 04:00:00 GMT 510(k) No: K252655 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252655 Mon, 11 May 2026 04:00:00 GMT 510(k) No: K260846 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260846 Mon, 11 May 2026 04:00:00 GMT 510(k) No: K261214 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261214 Mon, 11 May 2026 04:00:00 GMT 510(k) No: K252953 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252953 Mon, 11 May 2026 04:00:00 GMT 510(k) No: K253696 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253696 Mon, 11 May 2026 04:00:00 GMT 510(k) No: K260805 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260805 Mon, 11 May 2026 04:00:00 GMT 510(k) No: K254192 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254192 Tue, 12 May 2026 04:00:00 GMT 510(k) No: K260378 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260378 Tue, 12 May 2026 04:00:00 GMT 510(k) No: K260051 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260051 Tue, 12 May 2026 04:00:00 GMT 510(k) No: K260235 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260235 Tue, 12 May 2026 04:00:00 GMT 510(k) No: K260725 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260725 Tue, 12 May 2026 04:00:00 GMT 510(k) No: K260837 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260837 Tue, 12 May 2026 04:00:00 GMT 510(k) No: K260415 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260415 Tue, 12 May 2026 04:00:00 GMT 510(k) No: K260850 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260850 Tue, 12 May 2026 04:00:00 GMT 510(k) No: K252731 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252731 Tue, 12 May 2026 04:00:00 GMT 510(k) No: K261196 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261196 Tue, 12 May 2026 04:00:00 GMT 510(k) No: K260473 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260473 Tue, 12 May 2026 04:00:00 GMT 510(k) No: K252638 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252638 Wed, 13 May 2026 04:00:00 GMT 510(k) No: K252653 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252653 Wed, 13 May 2026 04:00:00 GMT 510(k) No: K260032 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260032 Wed, 13 May 2026 04:00:00 GMT 510(k) No: K261363 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261363 Wed, 13 May 2026 04:00:00 GMT 510(k) No: K254125 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254125 Wed, 13 May 2026 04:00:00 GMT 510(k) No: K253061 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253061 Wed, 13 May 2026 04:00:00 GMT 510(k) No: K253241 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253241 Wed, 13 May 2026 04:00:00 GMT 510(k) No: K254073 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254073 Wed, 13 May 2026 04:00:00 GMT 510(k) No: K253181 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253181 Wed, 13 May 2026 04:00:00 GMT 510(k) No: K252591 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252591 Wed, 13 May 2026 04:00:00 GMT 510(k) No: K261317 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261317 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K253883 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253883 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K260085 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260085 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K260565 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260565 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K252652 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252652 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K253372 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253372 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K252601 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252601 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K261134 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261134 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K260485 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260485 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K261224 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261224 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K260111 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260111 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K254133 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254133 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K253676 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253676 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K253078 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253078 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K260892 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260892 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K254048 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254048 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K254013 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254013 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K261241 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261241 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K252776 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252776 Thu, 14 May 2026 04:00:00 GMT 510(k) No: K250781 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250781 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K253235 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253235 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K252423 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252423 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K261264 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261264 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K260771 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260771 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K260536 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260536 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K252377 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252377 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K260059 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260059 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K252624 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252624 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K260989 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260989 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K261289 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261289 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K253935 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253935 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K252563 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252563 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K261273 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261273 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K253642 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253642 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K253756 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253756 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K253759 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253759 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K260134 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260134 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K254028 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254028 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K260506 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260506 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K254120 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254120 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K254050 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254050 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K252643 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252643 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K253716 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253716 Fri, 15 May 2026 04:00:00 GMT 510(k) No: K260840 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260840 Sat, 16 May 2026 04:00:00 GMT 510(k) No: K260522 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260522 Mon, 18 May 2026 04:00:00 GMT 510(k) No: K260100 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260100 Mon, 18 May 2026 04:00:00 GMT 510(k) No: K253831 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253831 Mon, 18 May 2026 04:00:00 GMT 510(k) No: K252047 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252047 Mon, 18 May 2026 04:00:00 GMT 510(k) No: K254109 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254109 Mon, 18 May 2026 04:00:00 GMT 510(k) No: K253295 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253295 Mon, 18 May 2026 04:00:00 GMT 510(k) No: K253454 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253454 Mon, 18 May 2026 04:00:00 GMT 510(k) No: K260268 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260268 Tue, 19 May 2026 04:00:00 GMT 510(k) No: K251270 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251270 Tue, 19 May 2026 04:00:00 GMT 510(k) No: K261071 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261071 Tue, 19 May 2026 04:00:00 GMT 510(k) No: K253722 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253722 Tue, 19 May 2026 04:00:00 GMT 510(k) No: K260577 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260577 Tue, 19 May 2026 04:00:00 GMT 510(k) No: K254024 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254024 Tue, 19 May 2026 04:00:00 GMT 510(k) No: K260146 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260146 Tue, 19 May 2026 04:00:00 GMT 510(k) No: K261299 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261299 Tue, 19 May 2026 04:00:00 GMT 510(k) No: K252985 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252985 Tue, 19 May 2026 04:00:00 GMT 510(k) No: K253309 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253309 Tue, 19 May 2026 04:00:00 GMT 510(k) No: K253596 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253596 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K261286 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261286 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K253774 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253774 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K253134 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253134 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K260351 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260351 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K253911 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253911 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K253570 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253570 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K260098 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260098 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K260594 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260594 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K260717 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260717 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K252707 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252707 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K252717 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252717 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K260304 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260304 Wed, 20 May 2026 04:00:00 GMT 510(k) No: K253245 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253245 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K261291 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261291 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K251920 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251920 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K254131 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254131 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K253191 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253191 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K261359 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261359 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K252746 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252746 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K254141 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254141 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K253112 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253112 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K253816 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253816 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K260580 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260580 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K260649 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260649 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K260582 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260582 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K260066 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260066 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K253352 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253352 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K260068 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260068 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K254244 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254244 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K261325 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261325 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K261315 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261315 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K260234 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260234 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K253956 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253956 Thu, 21 May 2026 04:00:00 GMT 510(k) No: DEN250028 - Decision: Granted http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=DEN250028 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K260962 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260962 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K260618 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260618 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K253720 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253720 Thu, 21 May 2026 04:00:00 GMT 510(k) No: K252915 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252915 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K252784 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252784 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K253569 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253569 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K260324 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260324 Fri, 22 May 2026 04:00:00 GMT 510(k) No: DEN250057 - Decision: Granted http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=DEN250057 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K253949 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253949 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K252887 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252887 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K252917 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252917 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K260695 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260695 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K260560 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260560 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K254137 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254137 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K254129 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254129 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K253060 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253060 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K252735 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252735 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K261098 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261098 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K260113 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260113 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K260329 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260329 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K253359 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253359 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K253773 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253773 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K260189 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260189 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K252772 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252772 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K261280 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261280 Fri, 22 May 2026 04:00:00 GMT 510(k) No: K260183 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260183 Sun, 24 May 2026 04:00:00 GMT 510(k) No: K252790 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252790 Tue, 26 May 2026 04:00:00 GMT 510(k) No: K260398 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260398 Tue, 26 May 2026 04:00:00 GMT 510(k) No: K254157 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254157 Tue, 26 May 2026 04:00:00 GMT 510(k) No: K252797 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252797 Tue, 26 May 2026 04:00:00 GMT 510(k) No: K253629 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253629 Tue, 26 May 2026 04:00:00 GMT 510(k) No: K252833 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252833 Tue, 26 May 2026 04:00:00 GMT 510(k) No: K260318 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260318 Tue, 26 May 2026 04:00:00 GMT 510(k) No: K254075 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254075 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K254102 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254102 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K261374 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261374 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K260142 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260142 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K260367 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260367 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K260207 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260207 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K260123 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260123 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K260680 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260680 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K254104 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254104 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K260646 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260646 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K253212 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253212 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K254265 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254265 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K253971 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253971 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K252930 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252930 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K253130 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253130 Wed, 27 May 2026 04:00:00 GMT 510(k) No: K252712 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252712 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K253931 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253931 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K260213 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260213 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K252702 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252702 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K252823 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252823 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K253894 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253894 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K260895 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260895 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K261405 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261405 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K253530 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253530 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K260295 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260295 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K261037 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261037 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K254092 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254092 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K260423 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260423 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K251840 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251840 Thu, 28 May 2026 04:00:00 GMT 510(k) No: K254300 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254300 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K252396 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252396 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K254076 - Decision: Substantially Equivalent - Kit http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254076 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K253119 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253119 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K261369 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261369 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K260138 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260138 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K261202 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261202 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K260489 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260489 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K252840 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252840 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K252947 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252947 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K260507 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260507 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K252859 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252859 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K260262 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260262 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K261038 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261038 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K260077 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260077 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K252965 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252965 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K252821 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252821 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K252802 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252802 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K261159 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261159 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K261060 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261060 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K253103 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253103 Fri, 29 May 2026 04:00:00 GMT 510(k) No: K261154 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261154 Sat, 30 May 2026 04:00:00 GMT 510(k) No: K253882 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253882 Mon, 01 Jun 2026 04:00:00 GMT 510(k) No: K260456 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260456 Mon, 01 Jun 2026 04:00:00 GMT 510(k) No: K261541 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261541 Mon, 01 Jun 2026 04:00:00 GMT 510(k) No: K260642 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260642 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K261002 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261002 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K260569 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260569 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K261093 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261093 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K253918 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253918 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K261540 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261540 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K260270 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260270 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K260364 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260364 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K260571 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260571 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K253803 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253803 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K252816 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252816 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K253507 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253507 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K252532 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252532 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K252844 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252844 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K253302 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253302 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K253195 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253195 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K252899 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252899 Tue, 02 Jun 2026 04:00:00 GMT 510(k) No: K261826 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261826 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K261840 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261840 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K261522 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261522 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K252854 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252854 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260116 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260116 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K261530 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261530 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260780 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260780 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260726 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260726 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260373 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260373 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K252800 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252800 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K261439 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261439 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K253974 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253974 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K254034 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254034 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260703 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260703 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K253124 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253124 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K252904 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252904 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K261484 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261484 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260715 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260715 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260179 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260179 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260806 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260806 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K260402 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260402 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K253600 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253600 Wed, 03 Jun 2026 04:00:00 GMT 510(k) No: K253020 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253020 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K260690 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260690 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253984 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253984 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K260770 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260770 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253102 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253102 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K260497 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260497 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253004 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253004 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K254209 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254209 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K252575 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252575 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K261510 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261510 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253553 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253553 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K261519 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261519 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253602 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253602 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253893 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253893 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253994 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253994 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K260956 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260956 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253026 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253026 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K260662 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260662 Thu, 04 Jun 2026 04:00:00 GMT 510(k) No: K253296 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253296 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K251684 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251684 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K260754 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260754 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K260289 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260289 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K253204 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253204 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K261492 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261492 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K260105 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260105 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K260301 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260301 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K260761 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260761 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K253656 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253656 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K243192 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243192 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K254086 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254086 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K253108 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253108 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K253162 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253162 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K260056 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260056 Fri, 05 Jun 2026 04:00:00 GMT 510(k) No: K261402 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261402 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K253257 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253257 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K251944 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251944 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K261352 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261352 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K253066 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253066 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K260332 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260332 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K253542 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253542 Mon, 08 Jun 2026 04:00:00 GMT 510(k) No: K251251 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251251 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K260748 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260748 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K261806 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261806 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K252914 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252914 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K260802 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260802 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K261549 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261549 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K253165 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253165 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K260864 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260864 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K260564 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260564 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K261621 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261621 Tue, 09 Jun 2026 04:00:00 GMT 510(k) No: K253192 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253192 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K261329 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261329 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K260855 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260855 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K254121 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254121 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K261016 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261016 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K253115 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253115 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K250690 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250690 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K261174 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261174 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K260614 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260614 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K260414 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260414 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K260810 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260810 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K253919 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253919 Wed, 10 Jun 2026 04:00:00 GMT 510(k) No: K253051 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253051 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K250129 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250129 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K250839 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250839 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K260653 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260653 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K251326 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251326 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K261251 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261251 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K260710 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260710 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K260859 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260859 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K260174 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260174 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K261610 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261610 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K260322 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260322 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K253052 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253052 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K253650 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253650 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K261292 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261292 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K260849 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260849 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K261256 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261256 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K254145 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254145 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K261209 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261209 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K254087 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254087 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K253607 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253607 Thu, 11 Jun 2026 04:00:00 GMT 510(k) No: K252932 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252932 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K253688 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253688 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K260406 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260406 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252963 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252963 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K260514 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260514 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K260935 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260935 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252937 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252937 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252933 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252933 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252987 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252987 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252996 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252996 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261213 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261213 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K253088 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253088 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K253196 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253196 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K260635 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260635 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K260346 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260346 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252323 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252323 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261204 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261204 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261366 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261366 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K253437 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253437 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261634 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261634 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K260102 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260102 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K252171 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252171 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261207 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261207 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K253015 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253015 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261175 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261175 Fri, 12 Jun 2026 04:00:00 GMT 510(k) No: K261604 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K261604 Sat, 13 Jun 2026 04:00:00 GMT