FDA product code · General, Plastic Surgery · Class 2
OHV: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
OHV is FDA's product code for "Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption": a Class 2 device classified under 21 CFR 878.4590, reviewed by the General, Plastic Surgery panel.
510(k) review time for OHV
Across 17 510(k) clearances under OHV decided from 2018-01-01 to 2026-10-06, the median was 89 days from FDA receipt to decision. Half took between 70 and 122 days, and 80% were decided within 144 days. These are past clearances, not a forecast for a new submission.
| Fastest | 25 |
|---|---|
| 25th percentile | 70 |
| Median | 89 |
| 75th percentile | 122 |
| 80th percentile | 144 |
| 90th percentile | 230 |
| Slowest | 459 |
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 OHV
2 FDA recognized consensus standards cite OHV, among them IEC 62555 Edition 1.0 2013-11; IEC 60601-2-62 Edition 1.0 2013-07. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-280 IEC 62555 Edition 1.0 2013-11 — Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
- 12-281 IEC 60601-2-62 Edition 1.0 2013-07 — Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.