# NHK: Resuscitator, Manual, Non Self-Inflating

- Device class: 2; regulation: 21 CFR 868.5905; FDA's rule: 510(k) required
- FDA decisions: 10
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1982: 1
- 1989: 1
- 1994: 2
- 1995: 1
- 1997: 1
- 2000: 1
- 2001: 1
- 2002: 1
- 2009: 1

## Most-cited predicates
- K940255: Hyperinflation Bag System (1994), cited by 1
- K092687: Venti.Plus Hyperinflation Bag System with Pressure Manometer (2009), cited by 1
- K970785: Sims Hyperinflation Bag System (1997), cited by 1

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