Cleared Traditional

K122132 - AVANCE FOAM DRESSING KIT INCL. TRANSPAR...

K122132 is an FDA 510(k) clearance for AVANCE FOAM DRESSING KIT INCL. TRANSPAR..., manufactured by Molnlycke Health Care. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K122132 · Molnlycke Health Care · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
183d
Days
Class 2
Risk

K122132 is an FDA 510(k) clearance for the AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM,.... Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Molnlycke Health Care (Norcross, US). The FDA issued a Cleared decision on January 17, 2013 after a review of 183 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.

View all Molnlycke Health Care devices

FDA 510(k) Submission Details - K122132

510(k) Number K122132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2012
Decision Date January 17, 2013
Days to Decision 183 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
68d slower than avg
Panel avg: 115d · This submission: 183d
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 136
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K122132.
V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K132741 · Kci USA, Inc. · Nov 2013
RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE
K132446 · Smith & Nephew, Inc. · Oct 2013
KCI NPWT GAUZE DRESSING
K123507 · Kci USA, Inc. · Apr 2013
INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K113678 · Medela AG · Oct 2012
ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT
K120033 · Kci USA, Inc. · May 2012
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K112127 · Smith & Nephew, Inc. · May 2012