# BYG: Mask, Oxygen

- Device class: 1; regulation: 21 CFR 868.5580; FDA's rule: 510(k) exempt
- FDA decisions: 55
- Recalls: 22 (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)
- 1987: 2
- 1988: 1
- 1989: 3
- 1990: 2
- 1991: 6
- 1992: 2
- 1993: 2
- 1994: 3
- 1995: 4
- 1996: 2

## Most-cited predicates
- K942907: Jemsdal Mask (1994), cited by 1
- K962848: Hans Rudolph Nasal Cpap Mask (1996), cited by 1
- K801883: Peep Face Mask (1980), cited by 1

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