# JCT: Prosthesis, Tracheal, Expandable

- Device class: 2; regulation: 21 CFR 878.3720; FDA's rule: 510(k) required
- FDA decisions: 45
- 510(k) review time 2021–2025: median 154 days (middle half 130–221)
- Recalls: 49 (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)
- 2008: 1
- 2009: 1
- 2012: 1
- 2014: 3
- 2016: 1
- 2018: 1
- 2020: 1
- 2021: 2
- 2022: 1
- 2023: 1

## Most-cited predicates
- K963241: Ultraflex (1996), cited by 9
- K934116: Wallstent Tracheobronchial Prosthesis Modification (1994), cited by 6
- K012544: Vascular Architects Aspire Covered Stent and Controlled Expansion Delivery System (2001), cited by 5
- K082284: Aero Tracheobronchial Stent Technology System (2008), cited by 5
- K030947: Alveolus Inc., TB-STS Tracheobronchial Stent System (2003), cited by 4
- K945494: Wallstent (R) Tracheobronchial Endoprosthesis (1995), cited by 3
- K964121: Wallstent Tracheobronchial Endoprosthesis (1996), cited by 3
- K121048: Ultraflex Tracheobronchial Stent System- Sterile Uncovered (2012), cited by 3
- K982184: Wallstent Endoprosthesis (1998), cited by 3
- K062511: Aero Tracheobronchial Stent System, Model 90129-2XX (2007), cited by 2

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