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Prevena Incision Management System with Customizable Dressing

by Kci USA, Inc. (Kinetic Concepts, Inc.)

510(k) K123878

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

The PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING is a cutting-edge medical device designed to promote healing and reduce recovery time for patients undergoing surgical procedures. Featuring a negative pressure wound therapy powered suction pump, this system provides personalized care tailored to each patient's unique needs. By utilizing a customizable dressing, healthcare professionals can tailor the treatment plan to meet individual patient requirements.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK123878 Date15 Jan 2013ClearedStatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-1141-2014 FDA Class II initiated 30 Jan 2014
    • Terminated Z-1142-2014 FDA Class II initiated 30 Jan 2014
    • Terminated Z-1135-2014 FDA Class II initiated 30 Jan 2014
    • Terminated Z-1137-2014 FDA Class II initiated 30 Jan 2014
    • Terminated Z-1136-2014 FDA Class II initiated 30 Jan 2014
    • Terminated Z-1138-2014 FDA Class II initiated 30 Jan 2014
    • Terminated Z-1140-2014 FDA Class II initiated 30 Jan 2014
    • Terminated Z-1139-2014 FDA Class II initiated 30 Jan 2014

    Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OMP
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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