# KGB: Mask, Oxygen, Non-Rebreathing

- Device class: 1; regulation: 21 CFR 868.5570; FDA's rule: 510(k) exempt
- FDA decisions: 13
- Recalls: 8 (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)
- 1978: 1
- 1979: 2
- 1988: 1
- 1992: 1
- 1993: 2
- 1994: 4
- 1996: 1
- 1997: 1

## Most-cited predicates
- K933048: Laerdal (TM) Pocket Mask, Modification (1993), cited by 1

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