# BYP: Mouthpiece, Breathing

- Device class: 1; regulation: 21 CFR 868.5620; FDA's rule: 510(k) exempt
- FDA decisions: 25
- 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)
- 1980: 1
- 1981: 1
- 1982: 2
- 1984: 2
- 1985: 5
- 1986: 2
- 1987: 2
- 1989: 1
- 1994: 1
- 1996: 1

## Most-cited predicates
- K872037: Aerochamber (1987), cited by 4
- K822437: Monaghan Aerochamber (1982), cited by 1

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