# CBK: Ventilator, Continuous, Facility Use

- Device class: 2; regulation: 21 CFR 868.5895; FDA's rule: 510(k) required
- FDA decisions: 505
- 510(k) review time 2021–2025: median 267 days (middle half 136–355)
- Recalls: 212 (81 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2016: 4
- 2017: 6
- 2018: 4
- 2019: 8
- 2020: 5
- 2021: 6
- 2023: 5
- 2024: 9
- 2025: 4
- 2026: 3

## Most-cited predicates
- K961687: EVITA 4 (1996), cited by 11
- K902859: Servo Ventilator 300 (1991), cited by 10
- K981072: Esprit Ventilator (1998), cited by 10
- K041223: Modification to Servo-I Ventilator System, Model 64 87 800 E407E (2004), cited by 10
- K060647: LTV 1200 Ventilator (2006), cited by 9
- K051263: Evitaxl with Option Smartcare (2005), cited by 9
- K970839: Servo Ventilator 300A (1997), cited by 8
- K061627: Modification to I Vent 201 (2006), cited by 7
- K902506: 7200AE Microprocessor Ventilator W/Enhanced Hard. (1991), cited by 7
- K023366: Datex-Ohmeda 7900 Ventilator Enhancements (2003), cited by 7

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