FDA product code · Cardiovascular
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
7 FDA decisions since 2009. 22 recalls name this code, 12 of them Class I.
For the treatment of atrial fibrillation.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OAE 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 · OAE
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAE
Too few OAE 510(k)s in any year since 2007 to give a median.
Recalls per year · OAE
5in 2025
Class I (12 since 2007) Class II/III not classified
Adverse event reports per year · OAE
1,412in 2025
MAUDE reports naming product code OAE, 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 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 5 | 0 |
| 2011 | 14 | — | 1 | 69 |
| 2012 | 10 | — | 0 | 70 |
| 2013 | 10 | — | 0 | 111 |
| 2014 | 15 | — | 0 | 131 |
| 2015 | 15 | — | 0 | 274 |
| 2016 | 19 | — | 0 | 311 |
| 2017 | 15 | — | 0 | 387 |
| 2018 | 28 | — | 0 | 884 |
| 2019 | 34 | — | 1 | 908 |
| 2020 | 27 | — | 0 | 744 |
| 2021 | 31 | — | 0 | 914 |
| 2022 | 26 | — | 2 | 1,161 |
| 2023 | 43 | — | 1 | 1,311 |
| 2024 | 32 | — | 7 (7) | 2,098 |
| 2025 | 20 | — | 5 (5) | 1,412 |
| 2026 | 25 | — | 0 | — |
Planning a device in OAE? 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