Cleared Traditional

K113678 - INVIA MOTION NEGATIVE PRESSURE WOUND TH...

K113678 is the FDA 510(k) clearance for INVIA MOTION NEGATIVE PRESSURE WOUND TH... by Medela AG. It is a Class 2 General & Plastic Surgery device (product code OMP) cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K113678 · Medela AG · General & Plastic Surgery device
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Oct 2012
Decision
292d
Days
Class 2
Risk

K113678 is an FDA 510(k) clearance for the INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Medela AG (Dousman, US). The FDA issued a Cleared decision on October 1, 2012 after a review of 292 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 Medela AG devices

Submission Details

510(k) Number K113678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2011
Decision Date October 01, 2012
Days to Decision 292 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
177d slower than avg
Panel avg: 115d · This submission: 292d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 101
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K113678.
RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device
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RENASYS
K142979 · Smith & Nephew, Inc. · Apr 2015
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PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
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PICO
K111170 · Smith & Nephew, Inc. · Dec 2011
RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD
K110647 · Smith & Nephew, Inc. · Jun 2011