# BSR: Stylet, Tracheal Tube

- Device class: 1; regulation: 21 CFR 868.5790; FDA's rule: 510(k) exempt
- FDA decisions: 32
- Recalls: 13 (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)
- 1984: 2
- 1987: 1
- 1990: 1
- 1991: 4
- 1992: 4
- 1993: 2
- 1994: 4
- 1995: 5
- 1996: 4
- 2017: 1

## Most-cited predicates
- K952100: Rusch Endotracheal Tube Stylet (1995), cited by 1
- K922842: Stylet and Tracheal Lightwand (STL) (1992), cited by 1

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