# CCC: Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

- Device class: 2; regulation: 21 CFR 868.1150; FDA's rule: 510(k) required
- FDA decisions: 15
- 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)
- 1978: 1
- 1987: 1
- 1989: 1
- 1991: 1
- 1993: 1
- 1995: 1
- 1996: 1
- 1997: 4
- 1999: 1
- 2007: 1

## Most-cited predicates
- K951094: Point-of-Care Arterial Blood Gas Monitoring System (1996), cited by 3
- K953893: Paratrend 7 Intravascular Blood Gas Monitoring System (1997), cited by 2
- K963935: Olympus Critical Care Monitoring System (1997), cited by 1
- K972314: Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter Senior and Satellite Monitor System (1997), cited by 1

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