Cleared Traditional

K082211 - RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS

K082211 is an FDA 510(k) clearance for RENASYS-F NEGATIVE PRESSURE WOUND THERA..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K082211 · Smith & Nephew, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
100d
Days
Class 2
Risk

K082211 is an FDA 510(k) clearance for the RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS. 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 November 14, 2008 after a review of 100 days - within the typical 510(k) review window.

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.

View all Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K082211

510(k) Number K082211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2008
Decision Date November 14, 2008
Days to Decision 100 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K082211.
OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
K083357 · Kci USA, Inc. · Mar 2009
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K082426 · Smith & Nephew, Inc. · Sep 2008
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K080357 · Medela AG · Jul 2008
V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000
K063692 · Kci USA, Inc. · Jun 2007