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 Spiracur, Inc., Guard Medical, Inc. and Benq Materials Corporation.

18
Total
17
Cleared
113d
Avg days
2009
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 110d avg (recent)

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

18 devices
1–18 of 18
Cleared Sep 18, 2026
VacHeal Negative Pressure Wound Therapy System
K254160
VacHeal, LLC
General & Plastic Surgery · 270d
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
Cleared Nov 19, 2015
SNaP Wound Care System
K151710
Spiracur, Inc.
General & Plastic Surgery · 148d
Cleared Nov 25, 2014
SNaP Wound Care System
K142272
Spiracur, Inc.
General & Plastic Surgery · 102d
Cleared Mar 12, 2014
SNAP WOUND CARE SYSTEM
K132080
Spiracur, Inc.
General & Plastic Surgery · 250d
Cleared Feb 25, 2014
CISNAP CLOSED INCISION SYSTEM
K133137
Spiracur, Inc.
General & Plastic Surgery · 137d
Cleared Dec 01, 2011
SNAP WOUND CARE SYSTEM
K113032
Spiracur, Inc.
General & Plastic Surgery · 50d
Cleared Aug 29, 2011
SNAP WOUND CARE SYSTEM
K112341
Spiracur, Inc.
General & Plastic Surgery · 14d
Cleared Jul 28, 2011
SNAP (R) WOUND CARE SYSTEM
K111393
Spiracur, Inc.
General & Plastic Surgery · 71d
Cleared Jul 21, 2011
CI-SNAP WOUND CARE SYSTEM
K111006
Spiracur, Inc.
General & Plastic Surgery · 101d
Not Cleared Aug 07, 2009
SNAP WOUND CARE DEVICE
DEN080011
Spiracur, Inc.
General & Plastic Surgery · 277d

About Product Code OKO - Regulatory Context

510(k) Submission Activity

18 total 510(k) submissions under product code OKO since 2009, with 17 receiving FDA clearance (average review time: 113 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OKO Product Code

FDA review times for OKO submissions have been consistent, averaging 110 days recently vs 114 days historically.

OKO devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →