# K080278: Tabataba Cotester

- Pathway: 510(k) (Traditional)
- Applicant: Fim Medical
- Decided: Nov 28, 2008 after 298 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 K000962 (2000). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000962: Pico Smokerlyzer, Model EC-50, Bedfont Scientific, Ltd. (2000) Summary page 1.

## Most influential descendants
- K121768: Cosense (2012), 3 descendants of its own
- K130036: Cosense CO Monitor (2014), 2 descendants of its own
- K151107: CoSense ETCO Monitor (2015), 1 descendant of its own
- K253119: CoSense ETCO Monitor (2026), 0 descendants of its own
- K171129: CO Check Pro, CO Screen (2018), 0 descendants of its own

## Indications for use
The TABATABA® CO TESTER is for the monitoring of Carbon Monoxide in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It can also be used for ambient air monitoring. It is for use by health professionals.

Source page: https://510kreport.com/device/K080278
Methodology: https://510kreport.com/methodology