# K202508: Hemo-Lyte C Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Di-Chem, Inc.
- Decided: Aug 12, 2022 after 711 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: 4 generations back to K873155 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940601: Gambro Bicart 720G, C.G.H. Medical, Inc. (1994) Summary page 4.
- K013724: Bicart, Gambro Renal Products (2002) Summary page 4.
- K072760: Solcart B, B. Braun Medizintechnologie GmbH (2008) Summary page 4.
- K102194: Solcart B, B. Braun Avitum AG (2011) Summary page 4.

## Indications for use
The Di-Chem Inc. Hemo-Lyte C cartridge is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure, or intoxication with dialyzable substances.

Source page: https://510kreport.com/device/K202508
Methodology: https://510kreport.com/methodology