# CCM: Plethysmograph, Pressure

- Device class: 2; regulation: 21 CFR 868.1750; FDA's rule: 510(k) required
- FDA decisions: 11
- 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
- 1979: 1
- 1985: 4
- 1986: 1
- 1989: 1
- 1995: 1
- 2003: 1
- 2009: 1

## Most-cited predicates
- K853390: Infant Body Test (1986), cited by 1
- K852088: System 1085 Body Plethysmograph (1985), cited by 1
- K023796: MS Paed-Baby Body (2003), cited by 1

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