# BTS: Tube, Bronchial (W/Wo Connector)

- Device class: 2; regulation: 21 CFR 868.5720; FDA's rule: 510(k) required
- FDA decisions: 6
- Recalls: 1 (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)
- 1977: 1
- 1983: 1
- 1984: 1
- 1990: 1
- 1995: 2

## Most-cited predicates
- K771219: Broncho-Cath (1977), cited by 3

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