# K033118: Bipro Model SDS-CB200

- Pathway: 510(k) (Traditional)
- Applicant: Medical Solutions International
- Decided: Jun 28, 2004 after 272 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 K003560 (2001). 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)
- K003560: Mar Cor Services Bicarb System, Mar Cor Services, Inc. (2001) Summary page 2.

## Indications for use
BiPro Model SDS-CB200 is intended for use in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) to remote points of use. The bicarb is then mixed with purified water and acid to create the dialysate solution used in hemodialysis.

Source page: https://510kreport.com/device/K033118
Methodology: https://510kreport.com/methodology