510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223263Substantially Equivalent

Prevena Plus 125 Therapy Unit

3M, San Antionio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223263 is the FDA 510(k) clearance record for Prevena Plus 125 Therapy Unit, a class II device, cleared for 3M 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 one 510(k) clearance for 3M. As of , FDA records show one recall naming K223263.

Clearance record

Decision date
Received
(112 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
3M 6203 Farinon Dr., San Antionio TX
510(k) summary
Summary PDF
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