# K050066: C-CO2 Colorimetric CO2 Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Marquest Medical Products, Inc.
- Decided: Mar 1, 2005 after 48 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- 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 K023820 (2003). 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)
- K023820: CO2 Clip, Bregas AB (2003) Summary page 1.

## Indications for use
The C-CO2 colorimetric carbon dioxide indicator provides a semi-quantitative visualization of the C02 in the patient airway or in the gas exhaled from a patient. At is an adjunct to clinical assessment when verifying correct ET tube placement and respiration.

Source page: https://510kreport.com/device/K050066
Methodology: https://510kreport.com/methodology