# K023615: Gambro Polyflux 6 LR, 8 LR and 10 LR

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products
- Decided: May 6, 2003 after 190 days
- Product code: MSF (Hemodialyzer, Re-Use, High Flux)
- 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: 1 generation back to K010985 (2001). 1 ancestor in all.
10 later devices descend from it; 1 cites it directly.
0 of 12 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.

## 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
POLYFLUX LR is intended for use in hemodialysis for the treatment of acute and chronic renal failure. The POLYFLUX LR may be reprocessed for reuse on the same patient.

Source page: https://510kreport.com/device/K023615
Methodology: https://510kreport.com/methodology