Cleared Special

K093564 - SVED WOUND TREATMENT SYSTEM

K093564 is an FDA 510(k) clearance for SVED WOUND TREATMENT SYSTEM, manufactured by Innovative Therapies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Special 510(k) pathway after a 7-day FDA review.

K093564 · Innovative Therapies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
7d
Days
Class 2
Risk

K093564 is an FDA 510(k) clearance for the SVED WOUND TREATMENT SYSTEM. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Innovative Therapies, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on November 25, 2009 after a review of 7 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K093564

510(k) Number K093564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2009
Decision Date November 25, 2009
Days to Decision 7 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 115d · This submission: 7d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 214
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K093564.
PREVENA INCISION MANAGEMENT SYSTEM
K100821 · Kci USA, Inc. · Jun 2010
V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D
K093526 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Mar 2010
VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
K091585 · Kci USA, Inc. · Dec 2009
VENTURI NPWT V. II ADVANCED VACUUM SYSTEM
K090258 · Talley Medical · Aug 2009
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
K091470 · Smith & Nephew, Inc. · Jul 2009
GENADYNE A4-XLR8 WOUND VACUUM SYSTEM
K090638 · Genadyne Biotechnologies, Inc. · Apr 2009
K093564 · SVED WOUND TREATMENT SYSTEM
Download PDF FDA Summary Innovative Therapies,…