# OOY: Bronchial Thermoplasty System

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 1
- 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)
- 2010: 4
- 2011: 4
- 2012: 4
- 2013: 3
- 2014: 1
- 2015: 1
- 2018: 1
- 2021: 2
- 2022: 1

## Most-cited predicates

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