# ONZ: Mechanical Ventilator

- Device class: 2; regulation: 21 CFR 868.5895; FDA's rule: 510(k) required
- FDA decisions: 6
- Recalls: 0 (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)
- 2009: 1
- 2010: 2
- 2011: 1
- 2014: 1
- 2016: 1

## Most-cited predicates
- K131562: Breathe Niov Ventilation System (2014), cited by 1
- K102525: Breathe Technologies Ventilator and Accessories (BT-V2S) (2010), cited by 1
- K082982: Breathe Technologies Ventilator and Accessories (2009), cited by 1
- K103345: Breathe Technologies Ventilator and Accessories (BT-V2S) (2011), cited by 1
- K100528: Breathe Technologies Ventilator and Accessories BT-V2S (2010), cited by 1

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