Cleared Traditional

K123507 - KCI NPWT GAUZE DRESSING

K123507 is an FDA 510(k) clearance for KCI NPWT GAUZE DRESSING, manufactured by Kci USA, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K123507 · Kci USA, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
142d
Days
Class 2
Risk

K123507 is an FDA 510(k) clearance for the KCI NPWT GAUZE DRESSING. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Kci USA, Inc. (San Antonio, US). The FDA issued a Cleared decision on April 4, 2013 after a review of 142 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 Kci USA, Inc. devices

FDA 510(k) Submission Details - K123507

510(k) Number K123507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2012
Decision Date April 04, 2013
Days to Decision 142 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 115d · This submission: 142d
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 193
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K123507.
EXTRICARE 100CC/ 250CC/ 400CC CANISTERS
K132252 · Devon Medical · Sep 2013
VCARE A
K121817 · IVT Medical, Ltd. · Sep 2013
EXTRICARE NPWT FOOT DRESSING
K131464 · Devon Medical, Inc. · Aug 2013
FORYOU NPWT DEVICE
K113236 · Foryou Medical Electronics Co, Ltd. · Feb 2013
AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM
K122132 · Molnlycke Health Care · Jan 2013
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
K123878 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Jan 2013