# K990643: PS 15 Polysulfone Hollow Fiber Membrane Hemodialyzer, Model 239-015

- Pathway: 510(k) (Traditional)
- Applicant: Althin Medical AB an Affiliate of Baxter Intl
- Decided: Dec 7, 1999 after 284 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 K852251 (1985). 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)
- K945597: Altres (R) 170 Hemodialyzer, Althin Medical AB an Affiliate of Baxter Intl (1995) Summary page 1.
- K852251: Fresenius Hemoflow F60 & Fresenius Hemoflow F40, Seratronics, Inc. (1985) Summary page 1.

## Indications for use
The PS 15® Hemodialyzer is intended for hemodialysis in patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate.

Source page: https://510kreport.com/device/K990643
Methodology: https://510kreport.com/methodology