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 Smith & Nephew Medical Limited, Genadyne Biotechnologies, Inc. and Smith & Nephew Medical, Ltd..
FDA 510(k) Cleared Negative Pressure Wound Therapy Powered Suction Pump Devices (Product Code OMP)
About Product Code OMP - Regulatory Context
510(k) Submission Activity
209 total 510(k) submissions under product code OMP since 1997, with 209 receiving FDA clearance (average review time: 193 days).
Submission volume has declined in recent years - 12 submissions in the last 24 months compared to 19 in the prior period.
FDA Review Time
FDA review times for OMP submissions have been consistent, averaging 173 days recently vs 194 days historically.
OMP devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →