# BZD: Ventilator, Non-Continuous (Respirator)

- Device class: 2; regulation: 21 CFR 868.5905; FDA's rule: 510(k) required
- FDA decisions: 463
- 510(k) review time 2021–2025: median 207 days (middle half 136–260)
- Recalls: 61 (13 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 5
- 2018: 5
- 2019: 6
- 2020: 6
- 2021: 6
- 2022: 4
- 2023: 5
- 2024: 10
- 2025: 7
- 2026: 10

## Most-cited predicates
- K050359: Ultra Mirage II Mask (2005), cited by 13
- K023244: Mirage Full Face Mask Series 2 (2002), cited by 12
- K961783: Sullivan Vpap II ST Nasal Vpap System (1996), cited by 11
- K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876 (2000), cited by 10
- K991648: Reusable Contour II Nasal Mask (1999), cited by 9
- K042403: Mirage Swift (2004), cited by 9
- K022465: Modification to Nasal-Aire (2003), cited by 8
- K010263: Remstar Plus Cpap System (2001), cited by 8
- K090244: Swift FX (2009), cited by 7
- K013909: S7 Elite CP AP System (2002), cited by 7

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