# K070259: EC50 Toxco+ Breath Carbon Monoxide Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Bedfont Scientific, Ltd.
- Decided: Feb 21, 2008 after 391 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 K892841 (1989). 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)
- K892841: Bedfont EC50 Smokerlyzer Carbon Monoxide Monitor, Bedfont Technical Instruments, Ltd. (1989) Summary page 1.
- K000962: Pico Smokerlyzer, Model EC-50, Bedfont Scientific, Ltd. (2000) Summary page 1.

## Indications for use
The EC50 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/K070259
Methodology: https://510kreport.com/methodology