# K905794: Pall 3N1 Filter

- Pathway: 510(k) (Traditional)
- Applicant: Pall Biomedical Products Co.
- Decided: Jun 13, 1991 after 168 days
- Product code: FPB (Filter, Infusion Line)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K261403: Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter (2026), 0 descendants of its own

## Recalls of this device
- Jun 15, 2011 · Not classified · Z-2715-2011: Incorrect filter media used (0.2 um filter used instead of the required 1.2 um) within the TNA1 filter used with total parenteral nutrition mixtures.

Source page: https://510kreport.com/device/K905794
Methodology: https://510kreport.com/methodology