FDA product code · General, Plastic Surgery · Class U
QSY: Hemostatic Wound Dressing Without Thrombin Or Other Biologics
QSY is FDA's product code for "Hemostatic Wound Dressing Without Thrombin Or Other Biologics": a Class U device, reviewed by the General, Plastic Surgery panel.
510(k) review time for QSY
Across 28 510(k) clearances under QSY decided from 2018-01-01 to 2026-10-06, the median was 242 days from FDA receipt to decision. Half took between 160 and 332 days, and 80% were decided within 339 days. These are past clearances, not a forecast for a new submission.
| Fastest | 24 |
|---|---|
| 25th percentile | 160 |
| Median | 242 |
| 75th percentile | 332 |
| 80th percentile | 339 |
| 90th percentile | 605 |
| Slowest | 692 |
| Year | Median days | n |
|---|---|---|
| 2018 | 186 | 5 |
| 2023 | 586 | 7 |
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.
QSY in the public FDA record
| 510(k) clearances, all years | 127 |
|---|---|
| Establishment listings | 262 |
Counts of records, not of devices or events. Adverse event reports for QSY are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite QSY
No FDA recognized consensus standard cites QSY 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.