# K043244: Fresenius Optiflux F20NR, FF18NR, F16NR

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care North America
- Decided: Dec 20, 2004 after 27 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002277 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002277: Fresenius Optiflux 200NR, Fresenius Medical Care North America (2000) Summary page 2.
- K002761: Fresnius Hemoflow F7NR, F50NR, F70NR Hemodialyzers, Fresenius Medical Care North America (2000) Summary page 2.

## Most influential descendants
- K122952: Nipro Pureflux-L Hemodialyzer (2013), 0 descendants of its own

## Recalls of this device
- Feb 4, 2014 · Class II · Z-1106-2014: Dialysate Port Leak During Priming of the Dialyzers

## Indications for use
Optiflux F20NRe, F18NRe, and F16NRe dialyzers are designed for single use acute and chronic hemodialysis.

Source page: https://510kreport.com/device/K043244
Methodology: https://510kreport.com/methodology