FDA Product Code OKO: Negative Pressure Wound Therapy Non-powered Suction Apparatus
A Non-powered Suction Apparatus Indicated For Negative Pressure Wound Therapy (npwt) That Is Intended 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.
Leading manufacturers include Guard Medical, Inc..
FDA 510(k) Cleared Negative Pressure Wound Therapy Non-powered Suction Apparatus Devices (Product Code OKO)
About Product Code OKO - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code OKO since 2009, with 16 receiving FDA clearance (average review time: 104 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OKO have taken an average of 46 days to reach a decision - down from 117 days historically, suggesting improved FDA processing for this classification.
OKO devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →