# K030366: Bicard Mixing System

- Pathway: 510(k) (Traditional)
- Applicant: Dialysis Systems, Inc.
- Decided: Apr 19, 2004 after 440 days
- Product code: FIN (Tank, Holding, Dialysis)
- 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 K970674 (1997). 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)
- K970674: G.E.M. Water Systems, International, G.E.M. Water Systems (1997) Summary page 1.

## Indications for use
The intended use of the Dialysis Systems Inc. Bicarbonate Mixing System is the mixing of water and sodium bicarbonate powder for hemodialysis treatment and the delivery of the mixture to the treatment floor.

Source page: https://510kreport.com/device/K030366
Methodology: https://510kreport.com/methodology