# NHJ: Device, Positive Pressure Breathing, Intermittent

- Device class: 2; regulation: 21 CFR 868.5905; FDA's rule: 510(k) required
- FDA decisions: 26
- 510(k) review time 2021–2025: median 300 days (middle half 287–354)
- Recalls: 12 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2008: 1
- 2012: 2
- 2013: 2
- 2014: 3
- 2016: 1
- 2020: 3
- 2022: 1
- 2024: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- K002598: Emerson Cough Assist Model CA-3000 W/Automatic Timing and Model CM-3000 W/Manual Timing (2000), cited by 7
- K121955: Coughassist T70 Device (2012), cited by 6
- K072292: Negavent Plus Pegaso Cough, Model: DA-3 Plus (2008), cited by 5
- K895485: Bird (Ipv) Noncontinuous Ventilators (1989), cited by 3
- K200988: Maximus System (2020), cited by 2
- K120277: Vital Cough (2012), cited by 2
- K124032: Metaneb (2013), cited by 2
- K051964: Powerneb (2005), cited by 2
- K231728: BiWaze Clear System (2024), cited by 1
- K132988: Vital Cough (2014), cited by 1

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