# BTM: Ventilator, Emergency, Manual (Resuscitator)

- Device class: 2; regulation: 21 CFR 868.5915; FDA's rule: 510(k) required
- FDA decisions: 210
- 510(k) review time 2021–2025: median 205 days (middle half 180–267)
- Recalls: 76 (24 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: 1
- 2015: 1
- 2016: 1
- 2018: 2
- 2021: 1
- 2022: 1
- 2023: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K082092: Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep Valve (2008), cited by 4
- K973419: DMR Plus Disposable Manual Resuscitator (1998), cited by 4
- K042682: Ambu Spur II. Adult Single Patient Resuscitator (2004), cited by 4
- K924610: Baxter Adult/Pedi/Infant Single Use Man Resuscit (1993), cited by 3
- K053140: Ambu Mark IV Resuscitator (2005), cited by 3
- K042843: Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators (2004), cited by 3
- K062080: Resuscitation Timer, Model L770-CPR (2006), cited by 2
- K912203: Ems Single Use Manual Resuscitators (1991), cited by 2
- K944301: Hudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog Numbers: 5360 Through 5380 (1994), cited by 2
- K002846: Headstar's Manual Emergency Resuscitator (2001), cited by 2

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