# CBH: Device, Fixation, Tracheal Tube

- Device class: 1; regulation: 21 CFR 868.5770; FDA's rule: 510(k) exempt
- FDA decisions: 47
- Recalls: 6 (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: 4
- 1988: 3
- 1990: 7
- 1991: 3
- 1992: 4
- 1993: 4
- 1994: 6
- 1995: 4
- 1997: 1
- 2014: 1

## Most-cited predicates
- K843790: Tracheal Tube Fixation Device (1985), cited by 1

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