Cleared Special

K162129 - RENASYS-G Gauze Dressing Kits with Soft Port

K162129 is an FDA 510(k) clearance for RENASYS-G Gauze Dressing Kits with Soft..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Special 510(k) pathway after a 30-day FDA review.

K162129 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
30d
Days
Class 2
Risk

K162129 is an FDA 510(k) clearance for the RENASYS-G Gauze Dressing Kits with Soft Port. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (St Petersburg, US). The FDA issued a Cleared decision on August 31, 2016 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K162129

510(k) Number K162129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date August 31, 2016
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

OMP Device Classification - Class 2, Special Controls

Product Code OMP Negative Pressure Wound Therapy Powered Suction Pump
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
Definition 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 this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OMP Negative Pressure Wound Therapy Powered Suction Pump

All 194
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K162129.
VT·One, VT·One 60days
K161410 · Carilex Medical, Inc. · Oct 2016
PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
K161897 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Oct 2016
RENASYS GO
K152163 · Smith & Nephew, Inc. · Sep 2016
Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large
K161570 · Lc Medical Concepts, Inc. · Aug 2016
RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply
K153209 · Smith & Nephew Medical, Ltd. · Aug 2016
V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...
K160451 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Jun 2016