# BWC: Needle, Emergency Airway

- Device class: 2; regulation: 21 CFR 868.5090; FDA's rule: 510(k) required
- FDA decisions: 14
- Recalls: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1985: 1
- 1995: 1
- 1997: 1
- 2001: 2
- 2002: 2
- 2005: 1
- 2013: 1
- 2016: 1
- 2017: 1
- 2020: 1

## Most-cited predicates
- K010016: Melker Cuffed Emergency Cricothyrotomy Catheter (2001), cited by 6
- K013916: Melker Emergency Cricothyrotomy Catheter Set (2001), cited by 2
- K160200: Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set (2017), cited by 1
- K013252: Patil Emergency Cricothyrotomy Catheter Set (2002), cited by 1

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