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

510(k) Final Decisions Rendered since February 01, 2026 U.S. Food and Drug Administration - Center for Devices and Radiological Health http://www.fda.gov/cdrh/510khome.html en-us Tue, 10 Mar 2026 10:06:13 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: K252011 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252011 Mon, 02 Feb 2026 05:00:00 GMT 510(k) No: K251582 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251582 Mon, 02 Feb 2026 05:00:00 GMT 510(k) No: K252286 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252286 Mon, 02 Feb 2026 05:00:00 GMT 510(k) No: K252649 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252649 Mon, 02 Feb 2026 05:00:00 GMT 510(k) No: K251200 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251200 Mon, 02 Feb 2026 05:00:00 GMT 510(k) No: K252438 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252438 Tue, 03 Feb 2026 05:00:00 GMT 510(k) No: K252676 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252676 Tue, 03 Feb 2026 05:00:00 GMT 510(k) No: K253737 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253737 Tue, 03 Feb 2026 05:00:00 GMT 510(k) No: K253282 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253282 Tue, 03 Feb 2026 05:00:00 GMT 510(k) No: K250644 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250644 Tue, 03 Feb 2026 05:00:00 GMT 510(k) No: K253701 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253701 Tue, 03 Feb 2026 05:00:00 GMT 510(k) No: K252909 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252909 Tue, 03 Feb 2026 05:00:00 GMT 510(k) No: K253640 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253640 Tue, 03 Feb 2026 05:00:00 GMT 510(k) No: K252087 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252087 Tue, 03 Feb 2026 05:00:00 GMT 510(k) No: K252048 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252048 Tue, 03 Feb 2026 05:00:00 GMT 510(k) No: K260012 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260012 Wed, 04 Feb 2026 05:00:00 GMT 510(k) No: K260038 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260038 Wed, 04 Feb 2026 05:00:00 GMT 510(k) No: K260104 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260104 Wed, 04 Feb 2026 05:00:00 GMT 510(k) No: K250773 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250773 Wed, 04 Feb 2026 05:00:00 GMT 510(k) No: K252301 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252301 Wed, 04 Feb 2026 05:00:00 GMT 510(k) No: K252623 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252623 Wed, 04 Feb 2026 05:00:00 GMT 510(k) No: K260028 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260028 Thu, 05 Feb 2026 05:00:00 GMT 510(k) No: K253959 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253959 Thu, 05 Feb 2026 05:00:00 GMT 510(k) No: K251517 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251517 Thu, 05 Feb 2026 05:00:00 GMT 510(k) No: K253779 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253779 Thu, 05 Feb 2026 05:00:00 GMT 510(k) No: K251949 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251949 Thu, 05 Feb 2026 05:00:00 GMT 510(k) No: DEN250006 - Decision: Granted http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=DEN250006 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K243348 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243348 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K251577 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251577 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K252058 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252058 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K251614 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251614 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K253221 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253221 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K253852 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253852 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K253568 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253568 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K253780 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253780 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K243979 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243979 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K252873 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252873 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K252076 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252076 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K253927 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253927 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K251474 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251474 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K252726 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252726 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K251507 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251507 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K251218 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251218 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K251836 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251836 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K251543 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251543 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K252871 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252871 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K251423 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251423 Fri, 06 Feb 2026 05:00:00 GMT 510(k) No: K254033 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254033 Mon, 09 Feb 2026 05:00:00 GMT 510(k) No: K251591 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251591 Mon, 09 Feb 2026 05:00:00 GMT 510(k) No: K254236 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254236 Mon, 09 Feb 2026 05:00:00 GMT 510(k) No: K260073 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260073 Tue, 10 Feb 2026 05:00:00 GMT 510(k) No: K260119 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260119 Tue, 10 Feb 2026 05:00:00 GMT 510(k) No: K251515 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251515 Tue, 10 Feb 2026 05:00:00 GMT 510(k) No: K252751 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252751 Tue, 10 Feb 2026 05:00:00 GMT 510(k) No: K252175 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252175 Tue, 10 Feb 2026 05:00:00 GMT 510(k) No: K252459 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252459 Tue, 10 Feb 2026 05:00:00 GMT 510(k) No: K253545 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253545 Tue, 10 Feb 2026 05:00:00 GMT 510(k) No: K251672 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251672 Tue, 10 Feb 2026 05:00:00 GMT 510(k) No: K253140 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253140 Tue, 10 Feb 2026 05:00:00 GMT 510(k) No: K252179 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252179 Tue, 10 Feb 2026 05:00:00 GMT 510(k) No: K254016 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254016 Tue, 10 Feb 2026 05:00:00 GMT 510(k) No: K251592 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251592 Wed, 11 Feb 2026 05:00:00 GMT 510(k) No: K252084 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252084 Wed, 11 Feb 2026 05:00:00 GMT 510(k) No: K251992 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251992 Wed, 11 Feb 2026 05:00:00 GMT 510(k) No: K253049 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253049 Wed, 11 Feb 2026 05:00:00 GMT 510(k) No: K253488 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253488 Wed, 11 Feb 2026 05:00:00 GMT 510(k) No: K253032 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253032 Wed, 11 Feb 2026 05:00:00 GMT 510(k) No: K251813 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251813 Wed, 11 Feb 2026 05:00:00 GMT 510(k) No: DEN250007 - Decision: Granted http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=DEN250007 Wed, 11 Feb 2026 05:00:00 GMT 510(k) No: K253201 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253201 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K253354 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253354 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K252523 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252523 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K253972 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253972 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K253381 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253381 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K251732 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251732 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K251375 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251375 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K253490 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253490 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K253491 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253491 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K260108 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260108 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K254007 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254007 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K252490 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252490 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K251760 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251760 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K260177 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260177 Thu, 12 Feb 2026 05:00:00 GMT 510(k) No: K252512 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252512 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K254052 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254052 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K260130 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260130 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K252891 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252891 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K252565 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252565 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K243854 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243854 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K251619 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251619 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K252400 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252400 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K252685 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252685 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K251742 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251742 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K250233 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250233 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K253149 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253149 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K251928 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251928 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K251802 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251802 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K254105 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254105 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K253096 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253096 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K253092 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253092 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K253564 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253564 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K253089 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253089 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K251581 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251581 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K253133 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253133 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K252420 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252420 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K252422 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252422 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K251852 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251852 Fri, 13 Feb 2026 05:00:00 GMT 510(k) No: K251680 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251680 Tue, 17 Feb 2026 05:00:00 GMT 510(k) No: K253524 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253524 Tue, 17 Feb 2026 05:00:00 GMT 510(k) No: K254089 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254089 Tue, 17 Feb 2026 05:00:00 GMT 510(k) No: K250550 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250550 Tue, 17 Feb 2026 05:00:00 GMT 510(k) No: K252805 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252805 Tue, 17 Feb 2026 05:00:00 GMT 510(k) No: K260149 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260149 Tue, 17 Feb 2026 05:00:00 GMT 510(k) No: K253599 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253599 Tue, 17 Feb 2026 05:00:00 GMT 510(k) No: K253539 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253539 Wed, 18 Feb 2026 05:00:00 GMT 510(k) No: K252561 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252561 Wed, 18 Feb 2026 05:00:00 GMT 510(k) No: K253637 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253637 Wed, 18 Feb 2026 05:00:00 GMT 510(k) No: K252098 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252098 Wed, 18 Feb 2026 05:00:00 GMT 510(k) No: K252197 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252197 Wed, 18 Feb 2026 05:00:00 GMT 510(k) No: K253643 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253643 Wed, 18 Feb 2026 05:00:00 GMT 510(k) No: K260185 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260185 Wed, 18 Feb 2026 05:00:00 GMT 510(k) No: K253612 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253612 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K260308 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260308 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K252597 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252597 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K260205 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260205 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K253687 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253687 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K260163 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260163 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K252814 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252814 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K253398 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253398 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K252002 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252002 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K251903 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251903 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K253002 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253002 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K254188 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254188 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K254018 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254018 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K260218 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260218 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K253203 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253203 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K252733 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252733 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K254148 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254148 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K253623 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253623 Thu, 19 Feb 2026 05:00:00 GMT 510(k) No: K253445 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253445 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K252972 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252972 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K252500 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252500 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K252672 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252672 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K253653 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253653 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K253683 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253683 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K260181 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260181 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K254162 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254162 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K253660 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253660 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K253605 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253605 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K252989 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252989 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K252619 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252619 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K251653 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251653 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K251890 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251890 Fri, 20 Feb 2026 05:00:00 GMT 510(k) No: K251692 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251692 Sat, 21 Feb 2026 05:00:00 GMT 510(k) No: K253646 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253646 Sun, 22 Feb 2026 05:00:00 GMT 510(k) No: K253531 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253531 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K252795 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252795 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K253169 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253169 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K251864 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251864 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K253068 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253068 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K253228 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253228 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K253648 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253648 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K253244 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253244 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K251661 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251661 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K253666 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253666 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K260265 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260265 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K253486 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253486 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K260043 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260043 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K251587 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251587 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K253583 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253583 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K253631 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253631 Mon, 23 Feb 2026 05:00:00 GMT 510(k) No: K253186 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253186 Tue, 24 Feb 2026 05:00:00 GMT 510(k) No: K260217 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260217 Tue, 24 Feb 2026 05:00:00 GMT 510(k) No: K260377 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260377 Tue, 24 Feb 2026 05:00:00 GMT 510(k) No: K253978 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253978 Tue, 24 Feb 2026 05:00:00 GMT 510(k) No: K254267 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254267 Tue, 24 Feb 2026 05:00:00 GMT 510(k) No: K254055 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254055 Tue, 24 Feb 2026 05:00:00 GMT 510(k) No: K254247 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254247 Tue, 24 Feb 2026 05:00:00 GMT 510(k) No: K253714 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253714 Tue, 24 Feb 2026 05:00:00 GMT 510(k) No: K253707 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253707 Tue, 24 Feb 2026 05:00:00 GMT 510(k) No: K260287 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260287 Tue, 24 Feb 2026 05:00:00 GMT 510(k) No: K251678 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251678 Tue, 24 Feb 2026 05:00:00 GMT 510(k) No: K252599 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252599 Tue, 24 Feb 2026 05:00:00 GMT 510(k) No: K253996 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253996 Wed, 25 Feb 2026 05:00:00 GMT 510(k) No: K251724 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251724 Wed, 25 Feb 2026 05:00:00 GMT 510(k) No: K260222 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260222 Wed, 25 Feb 2026 05:00:00 GMT 510(k) No: K251687 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251687 Wed, 25 Feb 2026 05:00:00 GMT 510(k) No: K253472 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253472 Wed, 25 Feb 2026 05:00:00 GMT 510(k) No: K253559 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253559 Wed, 25 Feb 2026 05:00:00 GMT 510(k) No: K253789 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253789 Wed, 25 Feb 2026 05:00:00 GMT 510(k) No: K253578 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253578 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K251860 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251860 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K253791 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253791 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K253764 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253764 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K260254 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260254 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K252166 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252166 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K254017 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254017 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K254242 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254242 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K253328 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253328 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K254271 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254271 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K254182 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254182 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K253641 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253641 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K254251 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254251 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K253021 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253021 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K251700 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251700 Thu, 26 Feb 2026 05:00:00 GMT 510(k) No: K260292 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260292 Fri, 27 Feb 2026 05:00:00 GMT 510(k) No: K252448 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252448 Fri, 27 Feb 2026 05:00:00 GMT 510(k) No: K253828 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253828 Fri, 27 Feb 2026 05:00:00 GMT 510(k) No: K253829 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253829 Fri, 27 Feb 2026 05:00:00 GMT 510(k) No: K253778 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253778 Fri, 27 Feb 2026 05:00:00 GMT 510(k) No: K253536 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253536 Fri, 27 Feb 2026 05:00:00 GMT 510(k) No: K254249 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254249 Fri, 27 Feb 2026 05:00:00 GMT 510(k) No: K253535 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253535 Fri, 27 Feb 2026 05:00:00 GMT 510(k) No: K253797 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253797 Fri, 27 Feb 2026 05:00:00 GMT 510(k) No: K253695 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253695 Fri, 27 Feb 2026 05:00:00 GMT 510(k) No: K251998 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251998 Fri, 27 Feb 2026 05:00:00 GMT 510(k) No: K252714 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252714 Fri, 27 Feb 2026 05:00:00 GMT 510(k) No: K254229 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254229 Mon, 02 Mar 2026 05:00:00 GMT 510(k) No: K253593 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253593 Mon, 02 Mar 2026 05:00:00 GMT 510(k) No: K253798 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253798 Mon, 02 Mar 2026 05:00:00 GMT 510(k) No: K252487 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252487 Mon, 02 Mar 2026 05:00:00 GMT 510(k) No: K260003 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260003 Mon, 02 Mar 2026 05:00:00 GMT 510(k) No: K253380 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253380 Mon, 02 Mar 2026 05:00:00 GMT 510(k) No: K251777 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251777 Mon, 02 Mar 2026 05:00:00 GMT 510(k) No: K252531 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252531 Mon, 02 Mar 2026 05:00:00 GMT 510(k) No: K253771 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253771 Mon, 02 Mar 2026 05:00:00 GMT 510(k) No: K252632 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252632 Mon, 02 Mar 2026 05:00:00 GMT 510(k) No: K254054 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254054 Mon, 02 Mar 2026 05:00:00 GMT 510(k) No: K260353 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260353 Tue, 03 Mar 2026 05:00:00 GMT 510(k) No: K253920 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253920 Tue, 03 Mar 2026 05:00:00 GMT 510(k) No: K253818 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253818 Tue, 03 Mar 2026 05:00:00 GMT 510(k) No: K251940 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251940 Tue, 03 Mar 2026 05:00:00 GMT 510(k) No: K254245 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254245 Tue, 03 Mar 2026 05:00:00 GMT 510(k) No: K260682 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260682 Tue, 03 Mar 2026 05:00:00 GMT 510(k) No: K253845 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253845 Tue, 03 Mar 2026 05:00:00 GMT 510(k) No: K253874 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253874 Tue, 03 Mar 2026 05:00:00 GMT 510(k) No: K251793 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251793 Tue, 03 Mar 2026 05:00:00 GMT 510(k) No: K260010 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260010 Tue, 03 Mar 2026 05:00:00 GMT 510(k) No: K252534 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252534 Tue, 03 Mar 2026 05:00:00 GMT 510(k) No: K254306 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K254306 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K253493 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253493 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K253565 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253565 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K260365 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260365 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K260380 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260380 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K253896 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253896 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: DEN250012 - Decision: Granted http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=DEN250012 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K251434 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251434 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K253898 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253898 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K253871 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253871 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K252025 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252025 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K253878 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253878 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K260015 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260015 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K253870 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253870 Wed, 04 Mar 2026 05:00:00 GMT 510(k) No: K252196 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252196 Thu, 05 Mar 2026 05:00:00 GMT 510(k) No: K253442 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253442 Thu, 05 Mar 2026 05:00:00 GMT 510(k) No: K251901 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251901 Thu, 05 Mar 2026 05:00:00 GMT 510(k) No: K252450 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252450 Thu, 05 Mar 2026 05:00:00 GMT 510(k) No: K252779 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252779 Thu, 05 Mar 2026 05:00:00 GMT 510(k) No: K253267 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253267 Thu, 05 Mar 2026 05:00:00 GMT 510(k) No: K252538 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252538 Thu, 05 Mar 2026 05:00:00 GMT 510(k) No: K253591 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253591 Thu, 05 Mar 2026 05:00:00 GMT 510(k) No: K260169 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260169 Thu, 05 Mar 2026 05:00:00 GMT 510(k) No: K251788 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251788 Thu, 05 Mar 2026 05:00:00 GMT 510(k) No: K253772 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253772 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K260166 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260166 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K260167 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260167 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K260013 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260013 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K253551 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253551 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K252208 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252208 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K253983 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253983 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K253951 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253951 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K251818 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251818 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K253262 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253262 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K251807 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K251807 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K253538 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253538 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K260361 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260361 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K253132 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253132 Fri, 06 Mar 2026 05:00:00 GMT 510(k) No: K253668 - Decision: Substantially Equivalent http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253668 Sun, 08 Mar 2026 05:00:00 GMT