Cleared Special

K052456 - MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM

K052456 is an FDA 510(k) clearance for MODIFICATION TO VERSATILE 1 WOUND VACUU..., manufactured by Blue Sky Medical Group Incorporated. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Special 510(k) pathway after a 58-day FDA review.

K052456 · Blue Sky Medical Group Incorporated · General & Plastic Surgery device
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Nov 2005
Decision
58d
Days
Class 2
Risk

K052456 is an FDA 510(k) clearance for the MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Blue Sky Medical Group Incorporated (Carlsbad, US). The FDA issued a Cleared decision on November 4, 2005 after a review of 58 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 Blue Sky Medical Group Incorporated devices

FDA 510(k) Submission Details - K052456

510(k) Number K052456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2005
Decision Date November 04, 2005
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

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 149
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K052456.
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K061788 · Boehringer Laboratories · Jul 2006
MEDELA VARIO SUCTION PUMPS
K061435 · Medela AG · Jun 2006
MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
K053627 · Kci USA, Inc. · Feb 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
MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS
K032310 · Kinetic Concepts, Inc. · Oct 2003