FDA cleared the Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter from Global Life Sciences Solutions USA, LLC on Aug 31, 2026 under K261403, a traditional 510(k). The device falls under product code FPB, Filter, Infusion Line, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.
FDA logged the submission as received on Apr 29, 2026. The decision came 124 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Global Life Sciences Solutions USA, LLC in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K261403?
K261403 is the FDA 510(k) for Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter, submitted by Global Life Sciences Solutions USA, LLC. FDA's decision date was Aug 31, 2026, under product code FPB (Filter, Infusion Line).
Who makes the Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter?
Global Life Sciences Solutions USA, LLC, based in Marlborough, MA, is the applicant of record for K261403.
How long did the K261403 review take?
FDA received the submission on Apr 29, 2026 and issued its decision on Aug 31, 2026, 124 days later.