Cleared Special

K151240 - extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc

K151240 is an FDA 510(k) clearance for extriCARE Negative Pressure Wound Thera..., manufactured by Devon Medical Products. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Special 510(k) pathway after a 29-day FDA review.

K151240 · Devon Medical Products · General & Plastic Surgery device
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Jun 2015
Decision
29d
Days
Class 2
Risk

K151240 is an FDA 510(k) clearance for the extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative.... Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Devon Medical Products (King Of Prussia, US). The FDA issued a Cleared decision on June 9, 2015 after a review of 29 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.

FDA 510(k) Submission Details - K151240

510(k) Number K151240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2015
Decision Date June 09, 2015
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
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 214
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K151240.
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
K151326 · Smith & Nephew, Inc. · Jul 2015
XLR8 PLUS (XLR8+)
K143726 · Genadyne Biotechnologies, Inc. · Jun 2015
Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters
K142626 · Medela AG · Jun 2015
Whisper Pump System
K142385 · Wound RX Medical, LLC · May 2015
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
K142646 · Genadyne Biotechnologies, Inc. · Apr 2015
RENASYS
K142979 · Smith & Nephew, Inc. · Apr 2015