# CCJ: Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

- Device class: 2; regulation: 21 CFR 868.1430; FDA's rule: 510(k) required
- FDA decisions: 28
- 510(k) review time 2021–2025: median 303 days (middle half 243–362)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2008: 2
- 2010: 1
- 2012: 1
- 2014: 1
- 2015: 1
- 2017: 1
- 2018: 1
- 2019: 1
- 2021: 2
- 2026: 1

## Most-cited predicates
- K082315: EC50 Micro+ Smokerlyzer (2010), cited by 2
- K171408: Carbon Monoxide Breath Sensor System (COBSS) (2017), cited by 2
- K080278: Tabataba Cotester (2008), cited by 2
- K000962: Pico Smokerlyzer, Model EC-50 (2000), cited by 2
- K892841: Bedfont EC50 Smokerlyzer Carbon Monoxide Monitor (1989), cited by 1
- K151107: CoSense ETCO Monitor (2015), cited by 1
- K902113: Vitalograph - Breathco Monitor (1990), cited by 1
- K130036: Cosense CO Monitor (2014), cited by 1
- K950197: Microco (1996), cited by 1
- K121768: Cosense (2012), cited by 1

Source page: https://510kreport.com/product-code/CCJ
Data by year (CSV): https://510kreport.com/product-code/CCJ.csv