Negative Pressure Wound Therapy Powered Suction Pump

What Is This Device?

For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

What Is FDA Product Code OMP?

Negative Pressure Wound Therapy Powered Suction Pump is FDA product code OMP, Class 2, 21 CFR 878.4780.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 6 clearances under this code; the FDA took a median of 328 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 47 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (14), Device Design (9) and Packaging change control (6).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.