# BTO: Tube, Tracheostomy (W/Wo Connector)

- Device class: 2; regulation: 21 CFR 868.5800; FDA's rule: 510(k) required
- FDA decisions: 129
- 510(k) review time 2021–2025: median 191 days (middle half 157–225)
- Recalls: 38 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2008: 1
- 2009: 1
- 2010: 3
- 2011: 1
- 2012: 1
- 2018: 1
- 2020: 1
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K811447: Shiley Disposable Cannula Trach. Tube (1981), cited by 6
- K810106: Shiley Single Cannula Tracheostomy Tube (1981), cited by 5
- K912124: Tracheostomy Tube and Cuff (1991), cited by 5
- K903730: D.I.C. Tracheostomy Tubes & Laryngectomy Tubes (1990), cited by 4
- K811033: Shiley Low Pressure Thin-Cuffed Trach (1981), cited by 4
- K030381: Portex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner Cannula (2003), cited by 4
- K173384: BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube (2018), cited by 3
- K030570: Blue Line Ultra Suctionaid Tracheostomy Tube (2003), cited by 3
- K865061: Shiley Dispos Cannula Fenes LP Cuffed Trache Tube (1987), cited by 2
- K060945: Portex Percutaneous Tracheostomy Kit (2006), cited by 2

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