# K171129: CO Check Pro, CO Screen

- Pathway: 510(k) (Traditional)
- Applicant: MD Diagnostics Limited
- Decided: Mar 2, 2018 after 319 days
- Product code: CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1430
- 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 K000962 (2000). 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)
- K080278: Tabataba Cotester, Fim Medical (2008) Summary page 4.
- K950197: Microco, Micro Direct, Inc. (1996) Summary page 4.

## Indications for use
For monitoring of carbon monoxide in adult exhaled breath. They are for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. Also can be used for ambient air monitoring. For use by healthcare professionals only in professional healthcare facilities.

Source page: https://510kreport.com/device/K171129
Methodology: https://510kreport.com/methodology