# CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

- Device class: 2; regulation: 21 CFR 868.1400; FDA's rule: 510(k) required
- FDA decisions: 307
- 510(k) review time 2021–2025: median 265 days (middle half 185–459)
- Recalls: 62 (8 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 5
- 2018: 6
- 2019: 7
- 2020: 4
- 2021: 4
- 2022: 3
- 2023: 4
- 2024: 3
- 2025: 3
- 2026: 3

## Most-cited predicates
- K042601: Capnostat 5 (2004), cited by 8
- K094012: CAPNOSTREAM20 with MICROMEDICO2 Module (2010), cited by 8
- K053174: Loflo C5 CO2 Sensor (2006), cited by 7
- K964239: Combination Oximeter/Carbon Dioxide Gas Analyzer (1997), cited by 7
- K944400: Pedi-Cap (1994), cited by 7
- K030886: Nico with Mars, Model 7300 (2003), cited by 6
- K951127: Hewlett-Packard Model M1026A Anesthetic Gas Module (1995), cited by 5
- K103604: Isa CO2, Isa AX+, Isa or+ (2011), cited by 5
- K012139: Vamos Anesthetic Gas Monitor (2002), cited by 5
- K894053: 2ND Modification of Fef (TM) End-Tidal CO2 Detector (1989), cited by 5

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