510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN180013Unknown

PREVENA 125 and PREVENA PLUS 125 Therapy Units

KCI USA, Inc., San Antonio TX / Direct, Unknown
FDA source (opens on fda.gov)

DEN180013 is the FDA 510(k) clearance record for PREVENA 125 and PREVENA PLUS 125 Therapy Units, a class II device, cleared for Kci USA, Inc. on under FDA product code QFC (Negative Pressure Wound Therapy Device For Reduction Of Wound Complications). FDA's definition for product code QFC reads: "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...". FDA records list 76 510(k) clearances for Kci USA, Inc., from to . As of , FDA records show no recalls naming DEN180013.

Clearance record

Decision date
Received
(400 days to decision)
Product code
QFC Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Regulation
21 CFR 878.4783
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kci USA, Inc. 6203 Farinon Dr., San Antonio TX
Third party review
No

Clearances, product code QFC

Trailing 12 months

FDA records hold no clearances under product code QFC in the trailing twelve months.

FDA records show no clearances under product code QFC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QFC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260