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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Infusion Line
510(k) Number K261403
Device Name Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter
Applicant
Global Life Sciences Solutions USA, LLC
100 Results Way
Marlborough,  MA  01752
Applicant Contact Brian Goetz
Correspondent
Global Life Sciences Solutions USA, LLC
100 Results Way
Marlborough,  MA  01752
Correspondent Contact Brian Goetz
Regulation Number880.5440
Classification Product Code
FPB  
Date Received04/29/2026
Decision Date 08/31/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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