Cleared Traditional

K132004 - NPWT WOUND DRESSING KIT- MEDIUM

K132004 is an FDA 510(k) clearance for NPWT WOUND DRESSING KIT- MEDIUM, manufactured by Creo Quality, LLC. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K132004 · Creo Quality, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
305d
Days
Class 2
Risk

K132004 is an FDA 510(k) clearance for the NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Creo Quality, LLC (Martinsville, US). The FDA issued a Cleared decision on May 2, 2014 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Creo Quality, LLC devices

FDA 510(k) Submission Details - K132004

510(k) Number K132004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date May 02, 2014
Days to Decision 305 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
190d slower than avg
Panel avg: 115d · This submission: 305d
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 147
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K132004.
SVED Wound Treatment System
K142916 · Cardinalhealth · Mar 2015
INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
K141926 · Medela AG · Dec 2014
XLR8 PLUS (XLR8+)
K141437 · Genadyne Biotechnologies, Inc. · Sep 2014
V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS
K133276 · Kci USA, Inc. · Nov 2013
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