# K240920: HemoCare Bicarbonate Concentrate Set (BCS)

- Pathway: 510(k) (Traditional)
- Applicant: Deka Research and Development
- Decided: Jul 12, 2024 after 99 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: 2 generations back to K873155 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013724: Bicart, Gambro Renal Products (2002) Summary page 5.

## Indications for use
The HemoCare Bicarbonate Concentrate Set (BCS) is indicated for use in the preparation of dialysate in a 3-stream proportioning hemodialysis machine with a compatible mechanical interface, such as the HemoCare Hemodialysis System. The BCS is intended for extracorporeal bicarbonate hemodialysis for chronic renal failure, according to a physician's prescription.

Source page: https://510kreport.com/device/K240920
Methodology: https://510kreport.com/methodology