FDA product code · General, Plastic Surgery · Class 2
QAI: Powered Microneedle Device
QAI is FDA's product code for "Powered Microneedle Device": a Class 2 device classified under 21 CFR 878.4430, reviewed by the General, Plastic Surgery panel.
510(k) review time for QAI
Across 25 510(k) clearances under QAI decided from 2018-01-01 to 2026-10-06, the median was 165 days from FDA receipt to decision. Half took between 103 and 252 days, and 80% were decided within 257 days. These are past clearances, not a forecast for a new submission.
| Fastest | 13 |
|---|---|
| 25th percentile | 103 |
| Median | 165 |
| 75th percentile | 252 |
| 80th percentile | 257 |
| 90th percentile | 266 |
| Slowest | 318 |
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 QAI
No FDA recognized consensus standard cites QAI 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.