FDA product code · General and plastic surgery
Low Energy Direct Current Thermal Ablation System
15 FDA decisions since 2006. 510(k) reviews decided 2021–2025 took a median of 203 days (half between 111 and 271). 3 recalls name this code, 0 of them Class I. The most-cited predicate is K183385, named by 4 later devices.
Ablation of soft tissue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OAB 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 · OAB
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OAB
129in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAB
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAB
10in 2025
MAUDE reports naming product code OAB, 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 1 | 82 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 1 | 16 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 10 |
| 2024 | 4 | 129 | 0 | 14 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 3 | 179 | 0 | — |
Planning a device in OAB? 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) ReportRelated product codes
Other codes under 21 CFR 878.4400.