# K002277: Fresenius Optiflux 200NR

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care North America
- Decided: Aug 25, 2000 after 30 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: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 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
- K031378: Fresenius Ultraflux Hemodialyzer (2003), 1 descendant of its own
- K122952: Nipro Pureflux-L Hemodialyzer (2013), 0 descendants of its own
- K034064: Fresenius Ultraflo HPX Hemodialyzer (2004), 0 descendants of its own
- K030050: Toraysulfone Dialyzer, BS-L Series (2003), 0 descendants of its own

## Recalls of this device
- Feb 4, 2014 · Class II · Z-1099-2014: Dialysate Port Leak During Priming of the Dialyzers
- Feb 4, 2014 · Class II · Z-1101-2014: Dialysate Port Leak During Priming of the Dialyzers
- Feb 4, 2014 · Class II · Z-1103-2014: Dialysate Port Leak During Priming of the Dialyzers
- May 14, 2010 · Not classified · Z-1951-2010: Hemodialyzer may leak at the header/end cap
- Dec 3, 2007 · Not classified · Z-0738-2008: Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.
- Nov 28, 2005 · Not classified · Z-0333-06: Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR

Source page: https://510kreport.com/device/K002277
Methodology: https://510kreport.com/methodology