OKO · Class II · 21 CFR 878.4683

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. and Benq Materials Corporation.

17
Total
16
Cleared
104d
Avg days
2009
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg 30d recently vs 114d historically

FDA 510(k) Cleared Negative Pressure Wound Therapy Non-powered Suction Apparatus Devices (Product Code OKO)

17 devices
1–17 of 17
Cleared May 15, 2025
NPseal
K251156
Guard Medical, Inc.
General & Plastic Surgery · 30d
Cleared Apr 08, 2025
NPseal
K250708
Guard Medical, Inc.
General & Plastic Surgery · 29d
Cleared Aug 15, 2024
NPseal (20 and 25)
K241522
Guard Medical, Inc.
General & Plastic Surgery · 78d
Cleared Feb 29, 2024
NPseal (Small, Medium, Large)
K240244
Guard Medical, Inc.
General & Plastic Surgery · 30d
Cleared Feb 10, 2022
NPseal
K212971
Guard Medical, Inc.
General & Plastic Surgery · 146d
Cleared May 14, 2021
NPseal
K211130
Guard Medical, Inc.
General & Plastic Surgery · 28d
Cleared May 26, 2020
NPseal
K200305
Guard Medical, Inc.
General & Plastic Surgery · 110d
Cleared May 04, 2020
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
K193185
Benq Materials Corporation
General & Plastic Surgery · 168d

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 remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - OKO Product Code

Recent submissions under OKO have taken an average of 30 days to reach a decision - down from 114 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 →