# K261403: Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter

- Pathway: 510(k) (Traditional)
- Applicant: Global Life Sciences Solutions USA, LLC
- Decided: Aug 31, 2026 after 124 days
- Product code: FPB (Filter, Infusion Line)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K905794 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905794: Pall 3N1 Filter, Pall Biomedical Products Co. (1991) Summary page 5.

## Indications for use
The Lipipor NLF1A, NLF2A, NLF2NTA, and TNA2A Infusion Filters are intended for use within the healthcare environment such as hospitals, healthcare facilities or clinical settings for infusion line filtering. The Lipipor Infusion Filters are indicated for the removal of inadvertent particulate debris and microbial contaminants larger than 1.2 pm and entrained air which may be found in intravenous solutions, parenteral nutrition admixtures, and injectable lipid emulsions. They are also indicated for the removal of inadvertent enlarged lipid droplets from parenteral nutrition admixtures and injectable lipid emulsions.

Source page: https://510kreport.com/device/K261403
Methodology: https://510kreport.com/methodology