Mini V.A.C., V.A.C. Freedom, V.A.C. Ats

• • Terminated Z-0379-06 FDA Unclassified (pre-2012) ·initiated 16 Sep 2005 ·on shared 510(k) K032310

  Possible mislabeling of shipping cartons.

• • Terminated Z-0038-05 FDA Unclassified (pre-2012) ·initiated 21 Sep 2004 ·on shared 510(k) K032310

  The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K032310 ↗

FDA Product Code

OMP

Device Class

Class II

Regulation

21 CFR Part 878.4780

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Cowboy II

  Class II

  FDA 510(k) K920308 Active Cleared 24 Aug 1992

• Kinair, Low Air Loss Bed

  Class II

  FDA 510(k) K843781 Active Cleared 28 Jan 1985

• Vacplus

  Class II

  FDA 510(k) K945062 Active Cleared 14 Mar 1995

• Modified Pedikair

  Class II

  FDA 510(k) K954320 Active Cleared 18 Jul 1997

• Glenn Bed

  Class II

  FDA 510(k) K931581 Active Cleared 21 Oct 1993

• Premium

  Class II

  FDA 510(k) K930673 Active Cleared 2 Aug 1993

See all devices from Kinetic Concepts, Inc. →