Cleared Special

K141437 - XLR8 PLUS (XLR8+)

K141437 is an FDA 510(k) clearance for XLR8 PLUS (XLR8+), manufactured by Genadyne Biotechnologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Special 510(k) pathway after a 112-day FDA review.

K141437 · Genadyne Biotechnologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
112d
Days
Class 2
Risk

K141437 is an FDA 510(k) clearance for the XLR8 PLUS (XLR8+). Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Genadyne Biotechnologies, Inc. (Hicksville, US). The FDA issued a Cleared decision on September 19, 2014 after a review of 112 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Genadyne Biotechnologies, Inc. devices

FDA 510(k) Submission Details - K141437

510(k) Number K141437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2014
Decision Date September 19, 2014
Days to Decision 112 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 115d · This submission: 112d
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 213
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K141437.
INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
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K141033 · Argentum Medical, LLC · Sep 2014
EXTRICARE
K132225 · Devon Medical, Inc. · May 2014
NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE
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