# K040255: Polyflux 14L, 17L, 21L Hemodialyzer/Filter Labeled for Single Use

- Pathway: 510(k) (Special)
- Applicant: Gambro Renal Products, Inc.
- Decided: May 24, 2004 after 110 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
Longest line of descent: 3 generations back to K955592 (1997). 5 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010985: Gambro Polyflux  6L, Gambro Polyflux 8L, Gambro Polyflux 10L, Model 6L, 8L, 10L, Gambro Renal Products (2001) Summary page 1.
- K030592: Gambro Polyflux, Model 140H, 170H, 210H, Gambro Renal Care Products (2003) Summary page 1.

## Most influential descendants
- 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
- K242053: FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (2025), 1 descendant of its own
- K240394: multiFlux 1000 (F00012408) (2024), 1 descendant of its own

## Indications for use
The capillary dialyzer Is intended for use in hemodialysis for the treatment of chronic and acute renal failure.

Source page: https://510kreport.com/device/K040255
Methodology: https://510kreport.com/methodology