# K173238: ToxCO

- Pathway: 510(k) (Traditional)
- Applicant: Bedfont Scientific, Ltd.
- Decided: Apr 4, 2019 after 546 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: 1 generation back to K082315 (2010). 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)
- K082315: EC50 Micro+ Smokerlyzer, Bedfont Scientific, Ltd. (2010) Summary page 5.

## Indications for use
The ToxCO® breath Carbon Monoxide monitor and accessories are used by healthcare professionals to determine levels of Carbon Monoxide (CO) poisoning.

Source page: https://510kreport.com/device/K173238
Methodology: https://510kreport.com/methodology