# MNT: Continuous, Minimal Ventilatory Support, Facility Use Ventilator

- Device class: 2; regulation: 21 CFR 868.5895; FDA's rule: 510(k) required
- FDA decisions: 25
- 510(k) review time 2021–2025: median 240 days (middle half 232–267)
- Recalls: 44 (6 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: 2
- 2012: 2
- 2013: 1
- 2017: 1
- 2020: 1
- 2022: 1
- 2023: 1
- 2024: 2
- 2025: 1
- 2026: 1

## Most-cited predicates
- K982454: Bipap Vision Ventilatory Support (1998), cited by 7
- K103167: Stellar 150 (2011), cited by 4
- K082660: V60 Ventilator, Model V8000 (2009), cited by 3
- K003075: Knightstar 330 Ventilator (2001), cited by 3
- K951264: Bipap Model S/T-D (1996), cited by 3
- K102985: V60 Ventilator with PPV and Auto-Trak+ Software Options (2011), cited by 2
- K955324: Bipap S/T-D 30 System (1996), cited by 2
- K213521: Nihon Kohden NKV-330 Ventilator System (2022), cited by 2
- K060044: Acute Care Face Mask, Model RT040 (2006), cited by 2
- K090113: Breas Vivo 40 System (2009), cited by 2

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