OMP · Class II · 21 CFR 878.4780

FDA Product Code OMP: Negative Pressure Wound Therapy Powered Suction Pump

FDA product code OMP covers powered suction pumps for negative pressure wound therapy.

These devices apply controlled sub-atmospheric pressure to a wound bed via a foam or gauze dressing and sealed film, promoting granulation tissue formation, reducing edema, and removing wound exudate. NPWT is used in the management of complex wounds, surgical incisions, and pressure injuries.

OMP devices are Class II medical devices, regulated under 21 CFR 878.4780 and reviewed by the FDA General & Plastic Surgery panel.

Leading manufacturers include Kci USA, Inc., Smith & Nephew Medical Limited and Genadyne Biotechnologies, Inc..

218
Total
218
Cleared
192d
Avg days
1997
Since
218 devices
169–192 of 218
Cleared Aug 08, 2011
ANTLIA III WOUND TREATMENT SYSTEM
K111333
Innovative Therapies, Inc.
General & Plastic Surgery · 88d
Cleared Jul 21, 2011
V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
K111280
Kci USA, Inc.
General & Plastic Surgery · 76d
Cleared Jun 22, 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
K110647
Smith & Nephew, Inc.
General & Plastic Surgery · 107d
Cleared Mar 14, 2011
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM
K103156
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 139d
Cleared Jan 24, 2011
WOUND PRO APEX
K100823
Accuro Medical Products, LLC
General & Plastic Surgery · 306d
Cleared Dec 15, 2010
V.A.C. GRANUFOAM SILVER SMALL DRESSING
K102956
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 72d
Cleared Sep 17, 2010
V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U
K100657
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 193d
Cleared Aug 06, 2010
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
K102001
Smith & Nephew, Inc.
General & Plastic Surgery · 22d
Cleared Jun 29, 2010
A4-XLR8 FOAM DRESSING
K092992
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 274d
Cleared Jun 11, 2010
PREVENA INCISION MANAGEMENT SYSTEM
K100821
Kci USA, Inc.
General & Plastic Surgery · 80d
Cleared Mar 10, 2010
V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D
K093526
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 114d
Cleared Dec 29, 2009
VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
K091585
Kci USA, Inc.
General & Plastic Surgery · 210d
Cleared Nov 25, 2009
SVED WOUND TREATMENT SYSTEM
K093564
Innovative Therapies, Inc.
General & Plastic Surgery · 7d
Cleared Aug 25, 2009
VENTURI NPWT V. II ADVANCED VACUUM SYSTEM
K090258
Talley Medical
General & Plastic Surgery · 204d
Cleared Jul 09, 2009
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
K091470
Smith & Nephew, Inc.
General & Plastic Surgery · 52d
Cleared Apr 29, 2009
GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
K090638
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 50d
Cleared Apr 02, 2009
ATMOS S041 WOUND
K090130
Atmos, Inc.
General & Plastic Surgery · 71d
Cleared Mar 04, 2009
OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
K083357
Kci USA, Inc.
General & Plastic Surgery · 111d
Cleared Feb 25, 2009
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
K083375
Smith & Nephew, Inc.
General & Plastic Surgery · 103d
Cleared Dec 18, 2008
GENADYNE A4 WOUND VACUUM SYSTEM
K082676
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 94d
Cleared Nov 25, 2008
PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
K082415
Premco Medical Systems, Inc.
General & Plastic Surgery · 96d
Cleared Nov 14, 2008
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
K082211
Smith & Nephew, Inc.
General & Plastic Surgery · 100d
Cleared Oct 09, 2008
NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K080275
Iasis Medical, Inc.
General & Plastic Surgery · 251d
Cleared Oct 08, 2008
EXSUDEX WOUND DRAINAGE PUMP
K082311
The Medical Company
General & Plastic Surgery · 56d