FDA Product Code QFC: Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
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.
Leading manufacturers include Smith and Nephew Medical Limited, 3M and Kci USA, Inc..
3
Total
2
Cleared
290d
Avg days
2019
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Negative Pressure Wound Therapy Device For Reduction Of Wound Complications Devices (Product Code QFC)
3 devices
Cleared
Feb 13, 2023
Prevena Plus 125 Therapy Unit
3M
General & Plastic Surgery
112d
Cleared
Dec 14, 2021
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
Smith and Nephew Medical Limited
General & Plastic Surgery
358d
Not Cleared
Apr 19, 2019
PREVENA 125 and PREVENA PLUS 125 Therapy Units
Kci USA, Inc.
General & Plastic Surgery
400d
About Product Code QFC - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QFC since 2019, with 2 receiving FDA clearance (average review time: 290 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.