# NOU: Continuous, Ventilator, Home Use

- Device class: 2; regulation: 21 CFR 868.5895; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 426 days (middle half 414–439)
- Recalls: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2003: 2
- 2004: 1
- 2013: 1
- 2016: 1
- 2021: 1
- 2025: 1

## Most-cited predicates
- K021981: Ivent 201 Portable Ventilator (2003), cited by 4
- K160481: Vivo 60 (2016), cited by 3
- K022750: PLV Continuum Ventilator, Model P1000 (2003), cited by 2
- K193586: Vivo 45 LS (2021), cited by 2
- K034032: PLV Continuum Ventilator, Model P2000 (2004), cited by 1
- K123144: VIVO 50 (2013), cited by 1

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