# K192928: Optiflux Enexa F500 Dialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care Reanal Therapies Group, LLC
- Decided: Jul 9, 2020 after 266 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: 10 generations back to K001283 (2001). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152367: Optiflux dialyzer, Fresenius Medical Care North America (2015) Summary page 4.

## Indications for use
Optiflux® Enexa™ dialyzers are intended for patients with acute kidney injury or chronic kidney disease when conservative therapy is judged to be inadequate.

Source page: https://510kreport.com/device/K192928
Methodology: https://510kreport.com/methodology