# MNS: Ventilator, Continuous, Non-Life-Supporting

- Device class: 2; regulation: 21 CFR 868.5895; FDA's rule: 510(k) required
- FDA decisions: 47
- 510(k) review time 2021–2025: median 267 days (middle half 179–350)
- Recalls: 4 (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)
- 2011: 3
- 2012: 5
- 2013: 3
- 2016: 2
- 2017: 1
- 2018: 1
- 2022: 1
- 2023: 1
- 2024: 1
- 2026: 3

## Most-cited predicates
- K060105: Vpap Iii ST-a/Kidsta Mask System (2006), cited by 8
- K033276: Vpap Iii ST-a (2004), cited by 5
- K092186: Vpap TX (2009), cited by 5
- K051364: Vpap Adapt (2005), cited by 5
- K012323: Bipap Synchrony Ventilatory Support System (2001), cited by 5
- K132371: Easycare Online (2013), cited by 4
- K031656: Bipap Harmony Ventilatory Support System (2003), cited by 4
- K063533: Bipap Synchrony (2007), cited by 4
- K070328: Bipap Synchrony with Avaps (2007), cited by 4
- K992530: Bipap Synchrony HC (2000), cited by 4

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