FDA product code · Cardiovascular
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
2 FDA decisions since 2011. No recall names this code.
Surgical cardiac ablation 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 OCM 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 · OCM
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCM
Too few OCM 510(k)s in any year since 2007 to give a median.
Recalls per year · OCM
No recall names OCM since 2007.
Adverse event reports per year · OCM
10in 2025
MAUDE reports naming product code OCM, 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 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 6 |
| 2022 | 5 | — | 0 | 5 |
| 2023 | 7 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 16 |
| 2025 | 5 | — | 0 | 10 |
| 2026 | 4 | — | 0 | — |
Planning a device in OCM? 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