# BTL: Ventilator, Emergency, Powered (Resuscitator)

- Device class: 2; regulation: 21 CFR 868.5925; FDA's rule: 510(k) required
- FDA decisions: 100
- 510(k) review time 2021–2025: median 203 days (middle half 196–278)
- Recalls: 17 (10 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2013: 1
- 2014: 7
- 2015: 1
- 2017: 2
- 2018: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2023: 1
- 2025: 1

## Most-cited predicates
- K892885: Resubmitted RD1000 Neopuff Infant Resuscitator (1989), cited by 12
- K931473: Impact Model 753 (1994), cited by 6
- K932170: Flynnr Genesis II a/C, a/O and Idlh (1993), cited by 6
- K070210: Giraffe and Panda  T- Piece Resuscitation System (2007), cited by 5
- K092085: Ispira Resuscitation Unit (2009), cited by 3
- K041473: Var-Plus (Vortran Automatic Resuscitator), Model PCM (2004), cited by 3
- K001430: Respirtech Pro-O2C, Model 2200 and Respirtech Pro, Model 2000 (2000), cited by 3
- K021520: Emt-Cpap (2002), cited by 2
- K973975: Respirtechpro (1998), cited by 2
- K051469: Carevent Atv+ and Carevent Mri (2005), cited by 2

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