# K970679: Altra Flux 200 Hemodialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Althin Medical AB an Affiliate of Baxter Intl
- Decided: Jul 23, 1998 after 514 days
- Product code: MSF (Hemodialyzer, Re-Use, High Flux)
- 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 K926373 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926373: Altra Flux 200 Hemodialyzer, Althin Medical AB an Affiliate of Baxter Intl (1995) Summary page 1.

## Indications for use
Altra Flux® 200 Hemodialyzers are intended for acute or chronic Hemodialysis. Hemodialysis is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. The Altra Flux 200 Hemodialyzer is indicated for single use or multiple use with the same patient.

Source page: https://510kreport.com/device/K970679
Methodology: https://510kreport.com/methodology