# K010985: Gambro Polyflux  6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products
- Decided: Oct 10, 2001 after 191 days
- Product code: KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Device class: 2
- Regulation: 21 CFR 876.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 3 cite it directly.
0 of 13 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
- K040255: Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use (2004), 10 descendants of its own
- K023615: Gambro Polyflux 6 LR, 8 LR and 10 LR (2003), 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/K010985
Methodology: https://510kreport.com/methodology