FDA product code QSY: Hemostatic Wound Dressing Without Thrombin Or Other Biologics
QSY is the FDA product code for hemostatic wound dressing without thrombin or other biologics. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 127 510(k) submissions under QSY, 17 in the last five years, from 67 different applicants. The average 510(k) review took 176 days (median 154); 187 days on average over the last three years.
Definition
To temporarily control bleeding and cover external wounds.
Classification
| Field | Value |
|---|---|
| Device name | Hemostatic Wound Dressing Without Thrombin Or Other Biologics |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for QSY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 257 |
| 2018 | 5 | 196 |
| 2019 | 4 | 262 |
| 2020 | 1 | 337 |
| 2021 | 1 | 202 |
| 2022 | 2 | 208 |
| 2023 | 7 | 461 |
| 2024 | 4 | 145 |
| 2025 | 2 | 169 |
| 2026 | 2 | 246 |
Compare with all 510(k) review times · Search every QSY clearance
Top QSY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtrade Products , Ltd. | 13 | 2023-11-17 |
| Hem Con Medical Technologies, Inc. | 9 | 2016-05-25 |
| Z-Medica Corporation | 7 | 2013-03-20 |
| Hemostasis, LLC | 5 | 2012-11-15 |
| Lifescience Plus, Inc. | 4 | 2026-04-30 |
62 more applicants have QSY clearances. See the full list in Caduvo.
Most recent QSY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253017 | Lifescience Plus, Inc. | BloodSTOP iX Trauma Matrix (TM-iX-20) | 2026-04-30 | 223 |
| K251700 | Speciality Fibres and Materials Limited | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm | 2026-02-26 | 269 |
| K250319 | Machina Medical, Inc. | MFUSE (MS001) | 2025-12-15 | 314 |
| K253609 | Cresilon, Inc. | TRAUMAGEL® 2.0 Hemostatic Gel | 2025-12-12 | 24 |
| K240713 | Cresilon, Inc. | TRAUMAGEL® | 2024-08-14 | 152 |
Recalls for QSY devices
openFDA lists no recalls for product code QSY.
Frequently asked questions
What is FDA product code QSY?
QSY is the FDA product code for hemostatic wound dressing without thrombin or other biologics. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is QSY?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code QSY?
Across 127 cleared submissions the average was 176 days from receipt to decision (median 154).
Which companies have the most QSY clearances?
Medtrade Products , Ltd. (13); Hem Con Medical Technologies, Inc. (9); Z-Medica Corporation (7); Hemostasis, LLC (5); Lifescience Plus, Inc. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code QSY
- Run a recall and safety report across every QSY manufacturer
- Watch product code QSY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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