Clearance Summary
Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter received FDA 510(k) clearance under submission number K261403, sponsored by Global Life Sciences Solutions USA, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2026-08-31.
- Submission: K261403
- Applicant / Sponsor: Global Life Sciences Solutions USA, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2026-08-31
Classification & Regulation
This clearance is catalogued under FDA product code FPB and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.