Cleared Traditional

K113199 - KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT

K113199 is an FDA 510(k) clearance for KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRE..., manufactured by Kevo Medical Supplies. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K113199 · Kevo Medical Supplies · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
273d
Days
Class 2
Risk

K113199 is an FDA 510(k) clearance for the KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Kevo Medical Supplies (Crofton, US). The FDA issued a Cleared decision on July 30, 2012 after a review of 273 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 Kevo Medical Supplies devices

FDA 510(k) Submission Details - K113199

510(k) Number K113199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2011
Decision Date July 30, 2012
Days to Decision 273 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
158d slower than avg
Panel avg: 115d · This submission: 273d
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 K113199.
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
PICO
K111170 · Smith & Nephew, Inc. · Dec 2011