Cleared Traditional

K092992 - A4-XLR8 FOAM DRESSING

K092992 is an FDA 510(k) clearance for A4-XLR8 FOAM DRESSING, 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 274-day FDA review.

K092992 · Genadyne Biotechnologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
274d
Days
Class 2
Risk

K092992 is an FDA 510(k) clearance for the A4-XLR8 FOAM DRESSING. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Genadyne Biotechnologies, Inc. (Crofton, US). The FDA issued a Cleared decision on June 29, 2010 after a review of 274 days - an extended review 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. 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 - K092992

510(k) Number K092992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2009
Decision Date June 29, 2010
Days to Decision 274 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
159d slower than avg
Panel avg: 115d · This submission: 274d
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 K092992.
V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT
K111280 · Kci USA, Inc. · Jul 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
K110647 · Smith & Nephew, Inc. · Jun 2011
MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY
K102001 · Smith & Nephew, Inc. · Aug 2010
PREVENA INCISION MANAGEMENT SYSTEM
K100821 · Kci USA, Inc. · Jun 2010
VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100
K091585 · Kci USA, Inc. · Dec 2009
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059
K091470 · Smith & Nephew, Inc. · Jul 2009