FDA product code QFC: Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
QFC is the FDA product code for negative pressure wound therapy device for reduction of wound complications. It is a Class II device, regulated under 21 CFR 878.4783 and reviewed by the General and Plastic Surgery panel. FDA has cleared 2 510(k) submissions under QFC, 1 in the last five years, from 2 different applicants. The average 510(k) review took 235 days (median 235). 1 De Novo request was granted under it. FDA has posted 1 recall for QFC devices, 1 initiated in the last five years.
Definition
A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds.
Classification
| Field | Value |
|---|---|
| Device name | Negative Pressure Wound Therapy Device For Reduction Of Wound Complications |
| Device class | Class II |
| Regulation | 21 CFR 878.4783 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QFC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 358 |
| 2023 | 1 | 112 |
Compare with all 510(k) review times · Search every QFC clearance
Top QFC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3M | 1 | 2023-02-13 |
| Smith and Nephew Medical Limited | 1 | 2021-12-14 |
Most recent QFC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223263 | 3M | Prevena Plus 125 Therapy Unit | 2023-02-13 | 112 |
| K203716 | Smith and Nephew Medical Limited | PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System | 2021-12-14 | 358 |
Recalls for QFC devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-01-17.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code QFC?
QFC is the FDA product code for negative pressure wound therapy device for reduction of wound complications. It is a Class II device, regulated under 21 CFR 878.4783 and reviewed by the General and Plastic Surgery panel.
What device class is QFC?
Class II, regulation 21 CFR 878.4783. Typical premarket route: 510(k).
How long does a 510(k) take for product code QFC?
Across 2 cleared submissions the average was 235 days from receipt to decision (median 235).
Which companies have the most QFC clearances?
3M (1); Smith and Nephew Medical Limited (1).
Have QFC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-01-17.
Next steps
- Run an FDA pathway report with predicate devices for product code QFC
- Run a recall and safety report across every QFC manufacturer
- Watch product code QFC 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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