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, a class II device type, regulated under 21 CFR 878.4683. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QPX
- Device name
- Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical
- FDA 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.
- Regulation
- 21 CFR 878.4683
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QPX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2021 | 1 |
Applicants with the most clearances
Product code QPX| Applicant | Clearances |
|---|---|
| Aatru Medical, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.