FDA product code · General, Plastic Surgery · Class 2
QAU: Hemostatic Device For Endoscopic Gastrointestinal Use
QAU is FDA's product code for "Hemostatic Device For Endoscopic Gastrointestinal Use": a Class 2 device classified under 21 CFR 878.4456, reviewed by the General, Plastic Surgery panel.
510(k) review time for QAU
Across 11 510(k) clearances under QAU decided from 2018-01-01 to 2026-10-06, the median was 195 days from FDA receipt to decision. Half took between 86 and 238 days, and 80% were decided within 246 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 86 |
| Median | 195 |
| 75th percentile | 238 |
| 80th percentile | 246 |
| 90th percentile | 686 |
| Slowest | 717 |
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 QAU
No FDA recognized consensus standard cites QAU 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.