Cleared Traditional

K082676 - GENADYNE A4 WOUND VACUUM SYSTEM

K082676 is an FDA 510(k) clearance for GENADYNE A4 WOUND VACUUM SYSTEM, manufactured by Genadyne Biotechnologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K082676 · Genadyne Biotechnologies, Inc. · General & Plastic Surgery device
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Dec 2008
Decision
94d
Days
Class 2
Risk

K082676 is an FDA 510(k) clearance for the GENADYNE A4 WOUND VACUUM SYSTEM. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Genadyne Biotechnologies, Inc. (Great Neck, US). The FDA issued a Cleared decision on December 18, 2008 after a review of 94 days - within the typical 510(k) review window.

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 Genadyne Biotechnologies, Inc. devices

FDA 510(k) Submission Details - K082676

510(k) Number K082676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date December 18, 2008
Days to Decision 94 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
21d faster than avg
Panel avg: 115d · This submission: 94d
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 136
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K082676.
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
K091470 · Smith & Nephew, Inc. · Jul 2009
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K083357 · Kci USA, Inc. · Mar 2009
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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
MEDELA INVIA WOUND THERAPY
K080357 · Medela AG · Jul 2008