# FJI: Dialyzer, Capillary, Hollow Fiber

- Device class: 2; regulation: 21 CFR 876.5820; FDA's rule: 510(k) required
- FDA decisions: 131
- 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)
- 1995: 14
- 1996: 5
- 1997: 3
- 1998: 4
- 1999: 4
- 2000: 2
- 2001: 2
- 2005: 1
- 2013: 1
- 2019: 1

## Most-cited predicates
- K902481: Gambro Alwall GFS Plus 11, 16 & 20 Hollow Fiber (1990), cited by 4
- K043342: Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR (2005), cited by 2
- K973291: Dynamic Hollow Fiber Dialyzer DC-Series (1997), cited by 2
- K926005: Fresenius Hemoflow, Various Models (1994), cited by 2
- K864831: Cobe Centrysystem 145E,160E,175E,190E Dialyzers (1987), cited by 2
- K874872: Fresenius Hemoflow F3, F4, F5, F7 (1988), cited by 1
- K854280: Clirans Taf Hollow Fiber Dialyzer (1985), cited by 1
- K190459: Hemoflow F3 and F4 Dialyzers (2019), cited by 1
- K011148: Ultraconcentrator System (2001), cited by 1
- K892375: Modified AM-Series Dialyzers (1989), cited by 1

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