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V.A.C. PLUS

by Kinetic Concepts, Inc.

510(k) K992448

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992448 Date18 Jan 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The V.A.C. PLUS is a Negative Pressure Wound Therapy Powered Suction Pump used for treating chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.

This device is supplied by Kinetic Concepts, Inc. and is authorized under FDA 510(k) number K992448 with product code OMP. It is regulated under 878.4780 and intended for use under the order of a physician in General and Plastic Surgery settings.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of wounds can be treated with the V.A.C. PLUS?

    The V.A.C. PLUS is used for treating chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.

  • How is the V.A.C. PLUS supplied?

    The V.A.C. PLUS is supplied by Kinetic Concepts, Inc. and is intended for use under the order of a physician in General and Plastic Surgery settings.

  • What is the regulatory status of the V.A.C. PLUS?

    The V.A.C. PLUS is authorized under FDA 510(k) number K992448 with product code OMP and is regulated under 878.4780.

  • In what medical settings is the V.A.C. PLUS intended to be used?

    The V.A.C. PLUS is intended for use under the order of a physician in General and Plastic Surgery settings.