# K240394: multiFlux 1000 (F00012408)

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: May 31, 2024 after 113 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: 12 generations back to K001283 (2001). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220721: FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000, Fresenius Medical Care Renal Therapies Group, LLC (2023) Summary page 4.

## Most influential descendants
- K252459: multiFlux 130 (F00013123); multiFlux 160 (F00013124) (2026), 0 descendants of its own

## Indications for use
The multiFlux 1000 dialyzers are intended for hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration in patients with acute kidney injury when conservative therapy is judged to be inadequate.

Source page: https://510kreport.com/device/K240394
Methodology: https://510kreport.com/methodology