# K031378: Fresenius Ultraflux Hemodialyzer

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care North America
- Decided: May 30, 2003 after 29 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002277 (2000). 1 ancestor in all.
1 later device descends 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)
- K002277: Fresenius Optiflux 200NR, Fresenius Medical Care North America (2000)

## Cited in the summary but kept off the family tree
- K982414: Gambro Polyflux 11S, 14S, 17S & 21S Hemodialyzers/ Hemofilters, Gambro Healthcare (1999). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K034064: Fresenius Ultraflo HPX Hemodialyzer (2004), 0 descendants of its own

## Indications for use
The Fresenius Ultraflux dialyzer is designed for single use acute and chronic hemodialysis.

Source page: https://510kreport.com/device/K031378
Methodology: https://510kreport.com/methodology