FDA product code · Physical Medicine · Class U
MLY: Vapocoolant Device
MLY is FDA's product code for "Vapocoolant Device": a Class U device, reviewed by the Physical Medicine panel.
510(k) review time for MLY
Across 10 510(k) clearances under MLY decided from 2018-01-01 to 2026-10-06, the median was 148 days from FDA receipt to decision. Half took between 100 and 180 days, and 80% were decided within 195 days. These are past clearances, not a forecast for a new submission.
| Fastest | 90 |
|---|---|
| 25th percentile | 100 |
| Median | 148 |
| 75th percentile | 180 |
| 80th percentile | 195 |
| 90th percentile | 262 |
| Slowest | 526 |
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 MLY
No FDA recognized consensus standard cites MLY 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.