FDA product code · Anesthesiology
Bronchial Thermoplasty System
1 FDA decision since 2010. No recall names this code.
Bronchial thermoplasty systems are intended for the treatment of severe persistent asthma in patients whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists to reduce the effects of their asthma by using thermal radiofrequency energy to ablate smooth muscle tissue in the patient's airways.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OOY at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · OOY
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · OOY
Too few OOY 510(k)s in any year since 2007 to give a median.
Recalls per year · OOY
No recall names OOY since 2007.
Adverse event reports per year · OOY
1in 2023
MAUDE reports naming product code OOY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 4 | — | 0 | 1 |
| 2011 | 4 | — | 0 | 8 |
| 2012 | 4 | — | 0 | 67 |
| 2013 | 3 | — | 0 | 82 |
| 2014 | 1 | — | 0 | 57 |
| 2015 | 1 | — | 0 | 64 |
| 2016 | 0 | — | 0 | 60 |
| 2017 | 0 | — | 0 | 70 |
| 2018 | 1 | — | 0 | 46 |
| 2019 | 0 | — | 0 | 37 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
Planning a device in OOY? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report