# K023820: CO2 Clip

- Pathway: 510(k) (Traditional)
- Applicant: Bregas AB
- Decided: May 7, 2003 after 173 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K050066: C-CO2 Colorimetric CO2 Indicator (2005), 0 descendants of its own

## Indications for use
The intended use of BreGas AB C02 Clip Indicator is to provide a semi-quantitative visualization of the COz in the patient airway or in the gas exhaled from a patient. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.

Source page: https://510kreport.com/device/K023820
Methodology: https://510kreport.com/methodology