FDA product code · General, Plastic Surgery · Class 2
OAB: Low Energy Direct Current Thermal Ablation System
OAB is FDA's product code for "Low Energy Direct Current Thermal Ablation System": a Class 2 device classified under 21 CFR 878.4400, reviewed by the General, Plastic Surgery panel.
510(k) review time for OAB
Across 10 510(k) clearances under OAB decided from 2018-01-01 to 2026-10-06, the median was 187 days from FDA receipt to decision. Half took between 159 and 250 days, and 80% were decided within 259 days. These are past clearances, not a forecast for a new submission.
| Fastest | 91 |
|---|---|
| 25th percentile | 159 |
| Median | 187 |
| 75th percentile | 250 |
| 80th percentile | 259 |
| 90th percentile | 287 |
| Slowest | 336 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FDA-recognized standards that cite OAB
No FDA recognized consensus standard cites OAB by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.
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