Cleared Special

SVED WOUND TREATMENT SYSTEM (K093564) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K093564 · Innovative Therapies, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Innovative Therapies, Inc. devices

Submission Details

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.

Device Classification

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 211
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K093564.
RENASYS EDGE (66803126)
K260646 · Smith & Nephew Medical, Ltd. · May 2026
Nisus NPWT Canister 500-mL (CPC-500)
K261291 · Cork Medical · May 2026
Wound Geni NPWT System
K254019 · Bechtel Medical, Inc. · May 2026
Genadyne ASTRA NPWT
K253429 · Genadyne Biotechnologies, Inc. · Mar 2026
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
K250586 · Deroyal Industries, Inc. · Nov 2025
extriCARE® 1000 Negative Pressure Wound Therapy System
K251646 · Alleva Medical Devices · Oct 2025