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, Medela AG and Deroyal Industries, Inc..
List of Negative Pressure Wound Therapy Powered Suction Pump devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Negative Pressure Wound Therapy Powered Suction Pump devices (product code OMP). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →