Cleared Traditional

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) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153209 · Smith & Nephew Medical, Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2016
Decision
273d
Days
Class 2
Risk

K153209 is an FDA 510(k) clearance for the RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENA.... Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Smith & Nephew Medical, Ltd. (Hull, GB). The FDA issued a Cleared decision on August 4, 2016 after a review of 273 days - an extended review 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K153209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2015
Decision Date August 04, 2016
Days to Decision 273 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 115d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 93
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K153209.
PICO 7 Single Use Negative Pressure Wound Therapy System
K172005 · Smith & Nephew Medical Limited · Feb 2018
RENASYS GO
K152163 · Smith & Nephew, Inc. · Sep 2016
RENASYS-G Gauze Dressing Kits with Soft Port
K162129 · Smith & Nephew, Inc. · Aug 2016
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device
K143133 · Smith & Nephew, Inc. · Jul 2015
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
K151326 · Smith & Nephew, Inc. · Jul 2015
RENASYS
K142979 · Smith & Nephew, Inc. · Apr 2015