# CAP: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

- Device class: 2; regulation: 21 CFR 868.2600; FDA's rule: 510(k) required
- FDA decisions: 78
- 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)
- 2010: 1
- 2011: 2
- 2012: 1
- 2013: 2
- 2014: 1
- 2015: 1
- 2016: 1
- 2018: 1
- 2019: 2
- 2020: 1

## Most-cited predicates
- K003497: Disposable Pressure Monitor (2000), cited by 4
- K992101: Criterion 40 or PM 40 (2000), cited by 4
- K040991: Ambu Disposable Pressure Manometer (2004), cited by 3
- K954486: Mercury Airway Pressure Manometer (1996), cited by 3
- K961318: 1ST Response Disposable Manometer (1996), cited by 2
- K873953: CM 5000R Remote Airway Pressure (1987), cited by 1
- K812140: Bird Mean Airway Pressure Monitor (1981), cited by 1
- K122077: Manometer (2013), cited by 1
- K904935: Respironics' Digital Manometer (1991), cited by 1
- K931394: CM5000R Remote Indicator (1993), cited by 1

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