# CCL: Analyzer, Gas, Oxygen, Gaseous-Phase

- Device class: 2; regulation: 21 CFR 868.1720; FDA's rule: 510(k) required
- FDA decisions: 122
- 510(k) review time 2021–2025: median 112 days (middle half 111–246)
- Recalls: 2 (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)
- 2007: 2
- 2008: 2
- 2011: 1
- 2013: 2
- 2016: 1
- 2018: 1
- 2022: 2
- 2023: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K051092: Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov, E-Caio, E-Covx, E-Cov, E-CO & Accesacc (2005), cited by 8
- K982619: HP Anesthesia Gas Monitor (Watertrap), Model A02 (1998), cited by 3
- K973282: Handi Oxygen Analyzer (1998), cited by 3
- K040484: MAXO2+, Model a and AE (2004), cited by 3
- K961644: Miniox 3000 Oxygen Monitor (1996), cited by 2
- K112402: ULTRAMAXO2 Oxygen Analyer (2011), cited by 2
- K063488: MAXO2 CU (2007), cited by 2
- K972992: Ceramatec Maxcell and Cag Galvanic Oxygen Sensors (1998), cited by 2
- K122290: Envitec Mysign O Oxygen Measuring Device (2013), cited by 2
- K984295: Invacare Check O2 Plus Concentrator Analyzer (Check O2 Plus) (1999), cited by 2

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