# FPB: Filter, Infusion Line

- Device class: 2; regulation: 21 CFR 880.5440; FDA's rule: 510(k) required
- FDA decisions: 99
- 510(k) review time 2021–2025: median 224 days (middle half 224–224)
- Recalls: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1994: 10
- 1995: 2
- 1997: 2
- 1998: 1
- 1999: 1
- 2002: 1
- 2011: 1
- 2015: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K896292: 1.2 Micron Filter with IV Set (1989), cited by 2
- K801343: B-D Filter Needle (1980), cited by 2
- K840248: IV-Filter (1984), cited by 1
- K993379: Pall Supor Aef Filter (1999), cited by 1
- K974661: 0.2 U Bacterial Filter (1998), cited by 1
- K021293: Arteria Blood Filter (2002), cited by 1
- K905794: Pall 3N1 Filter (1991), cited by 1
- K860746: Auto Syringe Micro Vol Ext Set W/Air Vent Filter (1986), cited by 1
- K894954: .22 & 1.2 Micron IV Filters (1989), cited by 1
- K943127: Pharmassure Large Volume Transfer Filters (1994), cited by 1

Source page: https://510kreport.com/product-code/FPB
Data by year (CSV): https://510kreport.com/product-code/FPB.csv