# K003498: Fresenius Optiflux 200A

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care North America
- Decided: Jan 4, 2001 after 52 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051187: Rexeed Series Dialyzers (2005), 20 descendants of its own
- K082414: Optiflux F250NR, Model 0500325E (2008), 16 descendants of its own
- 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

## Recalls of this device
- Feb 4, 2014 · Class II · Z-1104-2014: Dialysate Port Leak During Priming of the Dialyzers
- Mar 6, 2012 · Not classified · Z-1339-2012: Risk of internal blood leaks affecting the hemodialyzers.

Source page: https://510kreport.com/device/K003498
Methodology: https://510kreport.com/methodology