Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter— 510(k) K261403
Substantially EquivalentGlobal Life Sciences Solutions USA, LLC
FDA 510(k) clearance K261403 for Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter, Substantially Equivalent on 2026-08-31. Applicant: Global Life Sciences Solutions USA, LLC. Device class: 2.
Summary
Global Life Sciences Solutions USA's Lipipor submission lists four infusion filters: NLF1A, NLF2A, NLF2NTA, and TNA2A. They're filed under product code FPB, infusion line filters.
Class II, 21 CFR 880.5440. General Hospital is both the classification panel and the review panel, and the submission type is Traditional.
The applicant filed from Marlborough, Massachusetts. Review took 124 calendar days (April 29 to August 31, 2026) and ended in a substantially equivalent decision.
Clearance details
- Applicant
- Global Life Sciences Solutions USA, LLC
- Product code
- Product code FPB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
Recent devices under product code FPB
view allAdverse events under product code FPB
product code FPB- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.