# CBP: Valve, Non-Rebreathing

- Device class: 2; regulation: 21 CFR 868.5870; FDA's rule: 510(k) required
- FDA decisions: 103
- 510(k) review time 2021–2025: median 231 days (middle half 200–248)
- Recalls: 4 (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: 2
- 2011: 3
- 2014: 1
- 2015: 2
- 2016: 1
- 2017: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2024: 2

## Most-cited predicates
- K081516: Medsource CPR Mask with & Without Oxygen Port (2008), cited by 4
- K040366: Pressure Manifold, Model BC 110 (2004), cited by 3
- K042727: Pocket Size Resuscitator/Model: M16201R and M16201A (2005), cited by 2
- K833748: Rescue Valve (1983), cited by 2
- K861401: Laerdal Pocket Mask (1986), cited by 2
- K030943: Modification to Hiox (2003), cited by 1
- K934821: Cprotector (1994), cited by 1
- K112126: Genuine First Aid CPR Mask (2011), cited by 1
- K173770: OJR215 Pressure Relief Manifold (2019), cited by 1
- K142764: KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (2015), cited by 1

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