# K902481: Gambro Alwall GFS Plus 11, 16 & 20 Hollow Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Gambro, Inc.
- Decided: Jul 27, 1990 after 52 days
- Product code: FJI (Dialyzer, Capillary, Hollow Fiber)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 4 cite it directly.
0 of 24 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
- K030592: Gambro Polyflux, Model 140H, 170H, 210H (2003), 19 descendants of its own
- K040255: Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use (2004), 10 descendants of its own
- K043342: Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR (2005), 9 descendants of its own
- K220721: FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 (2023), 6 descendants of its own
- K243874: FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) (2025), 2 descendants of its own

Source page: https://510kreport.com/device/K902481
Methodology: https://510kreport.com/methodology