# K034064: Fresenius Ultraflo HPX Hemodialyzer

- Pathway: 510(k) (Special)
- Applicant: Fresenius Medical Care North America
- Decided: Jan 30, 2004 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002277 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
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) Summary page 1.
- K031378: Fresenius Ultraflux Hemodialyzer, Fresenius Medical Care North America (2003) Summary page 1.

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

Source page: https://510kreport.com/device/K034064
Methodology: https://510kreport.com/methodology