# K123262: Optiflux Ultra Dialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Jan 6, 2014 after 445 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: 8 generations back to K001283 (2001). 22 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082414: Optiflux F250NR, Model 0500325E, Fresenius Medical Care North America (2008) Summary page 1.
- K083778: Xenium XPH, Models 110, 130, 150, 170, 190 and 210, Baxter Healthcare Corporation (2009) Summary page 1.

## Most influential descendants
- K152367: Optiflux dialyzer (2015), 12 descendants of its own
- K162488: Optiflux dialyzer (2017), 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

## Indications for use
The Optiflux Ultra dialyzers are intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

Source page: https://510kreport.com/device/K123262
Methodology: https://510kreport.com/methodology