# K992564: AF-180 Hemodialyzer

- Pathway: 510(k) (Traditional)
- Applicant: Althin Medical AB
- Decided: Jan 18, 2000 after 169 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 K945542 (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)
- K945542: Altra Flux (TM) 170 Hemodialyzer, Althin Medical AB an Affiliate of Baxter Intl (1995) Summary page 1.

## Indications for use
Hemodialysis with Althin capillary dialyzers are indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate.

Source page: https://510kreport.com/device/K992564
Methodology: https://510kreport.com/methodology