# BTR: Tube, Tracheal (W/Wo Connector)

- Device class: 2; regulation: 21 CFR 868.5730; FDA's rule: 510(k) required
- FDA decisions: 242
- 510(k) review time 2021–2025: median 258 days (middle half 174–279)
- Recalls: 58 (20 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 2
- 2018: 5
- 2019: 5
- 2020: 3
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 7
- 2026: 2

## Most-cited predicates
- K042683: Well Lead Endotracheal Tube (2005), cited by 10
- K965132: HI-LO Evac and Evac II Endotracheal Tubes (1997), cited by 7
- K993786: Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy (2000), cited by 6
- K871204: Cuffed Tracheal Tube (Multiple) (1987), cited by 5
- K961837: Rush Oral/Nasal Tracheal Tube Cuffed Magill/Murphy (1996), cited by 5
- K931163: Rusch Agt PVC Preform Oral Trach Tub/Cuf W/Mur Eye (1993), cited by 4
- K082420: Tracheoscopic Ventilation Tube (TVT) (2008), cited by 4
- K032112: P0RTEX Reinforced Tracheal Tube (Cuffed and Uncuffed) (2004), cited by 4
- K934465: Dic Tracheostomy Tube and Portex Blue Line (1994), cited by 4
- K073383: Well Lead Reinforced Endotracheal Tube (2008), cited by 3

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