# NWA: Prosthesis, Tracheal, Preformed/Molded

- Device class: 2; regulation: 21 CFR 878.3720; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 160 days (middle half 95–226)
- Recalls: 0 (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)
- 1987: 1
- 1989: 1
- 1997: 1
- 2019: 1
- 2022: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K971509: Endoxane (1997), cited by 6
- K182743: Patient-Specific Airway Stent (2019), cited by 2
- K894380: Dumon Tracheobronchial Stent (1989), cited by 1

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