Cleared Traditional

K141847 - AVANCE FOAM DRESSING KITS

K141847 is an FDA 510(k) clearance for AVANCE FOAM DRESSING KITS, manufactured by Molnlycke Health Care Us, LLC. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K141847 · Molnlycke Health Care Us, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
260d
Days
Class 2
Risk

K141847 is an FDA 510(k) clearance for the AVANCE FOAM DRESSING KITS. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Molnlycke Health Care Us, LLC (Norcross, US). The FDA issued a Cleared decision on March 26, 2015 after a review of 260 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 Us, LLC devices

FDA 510(k) Submission Details - K141847

510(k) Number K141847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2014
Decision Date March 26, 2015
Days to Decision 260 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
145d slower than avg
Panel avg: 115d · This submission: 260d
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 157
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K141847.
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
K142646 · Genadyne Biotechnologies, Inc. · Apr 2015
RENASYS
K142979 · Smith & Nephew, Inc. · Apr 2015
Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home
K143016 · Cardinalhealth · Apr 2015
GENADYNE SPIRO FOAM DRESSING KIT
K141961 · Genadyne Biotechnologies, Inc. · Mar 2015
SVED Wound Treatment System
K142916 · Cardinalhealth · Mar 2015
INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K141926 · Medela AG · Dec 2014