# K082414: Optiflux F250NR, Model 0500325E

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Oct 28, 2008 after 68 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: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001283 (2001). 20 ancestors in all.
16 later devices descend from it; 2 cite 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)
- K062079: Xenium Dialyzer, Models 110, 130, 150, 170, 190 and 210, Baxter Healthcare Corporation (2006) Summary page 2.
- K051187: Rexeed Series Dialyzers, Asahi Kasei Medical Co., Ltd. (2005) Summary page 2.

## Most influential descendants
- K123262: Optiflux Ultra Dialyzer (2014), 13 descendants of its own
- 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

## Recalls of this device
- Feb 4, 2014 · Class II · Z-1105-2014: Dialysate Port Leak During Priming of the Dialyzers
- Dec 27, 2011 · Not classified · Z-0825-2012: Optiflux F250NRe Hemodialyzers have increased risk of an internal blood leak
- Feb 16, 2011 · Not classified · Z-1622-2011: There is an increased risk of an internal blood leak.

## Indications for use
The Fresenius Optiflux® F25ONR 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/K082414
Methodology: https://510kreport.com/methodology