# K002761: Fresnius Hemoflow F7NR, F50NR, F70NR Hemodialyzers

- Pathway: 510(k) (Traditional)
- Applicant: Fresenius Medical Care North America
- Decided: Dec 4, 2000 after 90 days
- Product code: FJI (Dialyzer, Capillary, Hollow Fiber)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K043244: Fresenius Optiflux F20NR, FF18NR, F16NR (2004), 1 descendant of its own
- K122952: Nipro Pureflux-L Hemodialyzer (2013), 0 descendants of its own

## Recalls of this device
- Feb 4, 2014 · Class II · Z-1098-2014: Dialysate Port Leak During Priming of the Dialyzers
- Feb 4, 2014 · Class II · Z-1102-2014: Dialysate Port Leak During Priming of the Dialyzers

Source page: https://510kreport.com/device/K002761
Methodology: https://510kreport.com/methodology