# K992475: Careside CO2, Total

- Pathway: 510(k) (Traditional)
- Applicant: Careside, Inc.
- Decided: Sep 15, 1999 after 51 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- 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 K903144 (1990). 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)
- K912844: Kodak Ektachem Dtii System, Eastman Kodak Company (1991) Summary page 1.
- K903144: Kodak Ektachem Clinical Chemistry Slides (ECO2), Eastman Kodak Company (1990) Summary page 1.

## Indications for use
For in vitro diagnostic use with the CARESIDE Analyzer™ to measure total CO₂ from anticoagulated whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with respiratory and metabolic disorders associated with acid-base imbalance.

Source page: https://510kreport.com/device/K992475
Methodology: https://510kreport.com/methodology