FDA product code QPX: Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
QPX is the FDA product code for negative pressure wound therapy, non-powered suction pump, chemical. It is a Class II device, regulated under 21 CFR 878.4683 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under QPX. The average 510(k) review took 452 days (median 452).
Definition
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. Indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Classification
| Field | Value |
|---|---|
| Device name | Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical |
| Device class | Class II |
| Regulation | 21 CFR 878.4683 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QPX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 452 |
Compare with all 510(k) review times · Search every QPX clearance
Top QPX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aatru Medical, LLC | 1 | 2021-08-23 |
Most recent QPX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201400 | Aatru Medical, LLC | npSIMS Negative Pressure Surgical Incision Management System (npSIMS) | 2021-08-23 | 452 |
Recalls for QPX devices
openFDA lists no recalls for product code QPX.
Frequently asked questions
What is FDA product code QPX?
QPX is the FDA product code for negative pressure wound therapy, non-powered suction pump, chemical. It is a Class II device, regulated under 21 CFR 878.4683 and reviewed by the General and Plastic Surgery panel.
What device class is QPX?
Class II, regulation 21 CFR 878.4683. Typical premarket route: 510(k).
How long does a 510(k) take for product code QPX?
Across 1 cleared submissions the average was 452 days from receipt to decision (median 452).
Which companies have the most QPX clearances?
Aatru Medical, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QPX
- Run a recall and safety report across every QPX manufacturer
- Watch product code QPX 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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