Cleared Special

K063426 - V.A.C. ATS LARGE (1000 ML) CANISTER WIT...

K063426 is the FDA 510(k) clearance for V.A.C. ATS LARGE (1000 ML) CANISTER WIT... by Kci USA, Inc.. It is a Class 2 General & Plastic Surgery device (product code OMP) cleared through the Special 510(k) pathway after a 30-day FDA review.

K063426 · Kci USA, Inc. · General & Plastic Surgery device
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Dec 2006
Decision
30d
Days
Class 2
Risk

K063426 is an FDA 510(k) clearance for the V.A.C. ATS LARGE (1000 ML) CANISTER WITH GEL, MODELS M6275093/5, M6275093/10. 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 December 13, 2006 after a review of 30 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 Kci USA, Inc. devices

Submission Details

510(k) Number K063426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2006
Decision Date December 13, 2006
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 101
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K063426.
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
K083375 · Smith & Nephew, Inc. · Feb 2009
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
K082211 · Smith & Nephew, Inc. · Nov 2008
RENASYS EZ
K082426 · Smith & Nephew, Inc. · Sep 2008
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K061788 · Boehringer Laboratories · Jul 2006
V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
K050261 · Kinetic Concepts, Inc. · May 2005
V.A.C. GRANUFOAM SILVER DRESSING
K041642 · Kinetic Concepts, Inc. · Jan 2005