# K990010: Althin Medical AB Altracart II

- Pathway: 510(k) (Traditional)
- Applicant: Althin Medical AB
- Decided: Apr 15, 1999 after 101 days
- Product code: KPO (Dialysate Concentrate For Hemodialysis (Liquid Or Powder))
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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 K873155 (1987). 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)
- K873155: Gambro Bicart System, Gambro, Inc. (1987) Summary page 3.
- K940601: Gambro Bicart 720G, C.G.H. Medical, Inc. (1994) Summary page 3.

## Indications for use
The Althin Medical AB Altracart II is indicated for the preparation of sodium bicarbonate containing hemodialysis solutions for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine / monitor and acid concentrate solutions.

Source page: https://510kreport.com/device/K990010
Methodology: https://510kreport.com/methodology