# K252459: multiFlux 130 (F00013123); multiFlux 160 (F00013124)

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Renal Therapies Group, LLC
- Decided: Feb 10, 2026 after 189 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: 13 generations back to K001283 (2001). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240394: multiFlux 1000 (F00012408), Fresenius Medical Care Renal Therapies Group, LLC (2024) Summary page 5.

## Cited in the summary but kept off the family tree
- K243784: Stryker Orthopaedics Hip Devices Labeling Update, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2025). Our reading of the summary gave K243784, FDA’s number for Stryker Orthopaedics Hip Devices Labeling Update (Howmedica Osteonics Corp., Dba Stryker Orthopaedics). Its FDA name has none of the distinctive words the summary uses for the device it names, “FX CorAL dialyzers”. Kept off the family tree. Summary page 5.

## Indications for use
The multiFlux 130 and 160 filters are intended for single use only for extracorporeal blood purification during continuous veno-venous hemofiltration (CVVH), continuous veno-venous hemodialysis (CVVHD), and continuous veno-venous hemodiafiltration (CVVHDF) using pre-, post- or mixed-dilution modes for patients suffering from acute kidney injury.

Source page: https://510kreport.com/device/K252459
Methodology: https://510kreport.com/methodology