FDA product code QSX: Hemostatic Wound Dressing With Thrombin Or Other Biologics
QSX is the FDA product code for hemostatic wound dressing with thrombin or other biologics. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 18 510(k) submissions under QSX, from 2 different applicants. The average 510(k) review took 75 days (median 42).
Definition
To temporarily control bleeding and cover external wounds.
Classification
| Field | Value |
|---|---|
| Device name | Hemostatic Wound Dressing With 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 QSX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 99 |
Compare with all 510(k) review times · Search every QSX clearance
Top QSX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vascular Solutions, Inc. | 17 | 2011-04-08 |
| Vascular Solutions, LLC | 1 | 2020-06-26 |
Most recent QSX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200720 | Vascular Solutions, LLC | D-Stat Radial Topical Hemostat | 2020-06-26 | 99 |
| K102212 | Vascular Solutions, Inc. | D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER | 2011-04-08 | 245 |
| K092612 | Vascular Solutions, Inc. | D-STAT RAD-BAND, RAD-BAND, MODELS 3501, 3505 | 2009-09-11 | 16 |
| K083190 | Vascular Solutions, Inc. | D-STAT DRY WRAP HEMOSTATIC BANDAGE, MODEL: 3015 | 2008-11-12 | 14 |
| K073264 | Vascular Solutions, Inc. | D-STAT DRY CLEAR HEMOSTATIC BANDAGE, MODEL 3005 | 2007-12-07 | 17 |
Recalls for QSX devices
openFDA lists no recalls for product code QSX.
Frequently asked questions
What is FDA product code QSX?
QSX is the FDA product code for hemostatic wound dressing with thrombin or other biologics. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is QSX?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code QSX?
Across 18 cleared submissions the average was 75 days from receipt to decision (median 42).
Which companies have the most QSX clearances?
Vascular Solutions, Inc. (17); Vascular Solutions, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QSX
- Run a recall and safety report across every QSX manufacturer
- Watch product code QSX 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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