Cleared Traditional

K113678 - INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM

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

K113678 · Medela AG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K113678

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
Combination Product No
PCCP Authorized No
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.

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 193
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K113678.
VOLTERA POWERED SUCTION PUMP
K112853 · Suzric Enterprise Co., Ltd. · Nov 2012
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT
K121883 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Oct 2012
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
K120499 · Kci USA, Inc. (Kinetic Concepts, Inc.) · Oct 2012
SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300
K113291 · Simex Medizintechnik GmbH · Aug 2012
KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT
K113199 · Kevo Medical Supplies · Jul 2012
AC WOUND TREATMENT SYSTEM
K111949 · Nanovibronix, Inc. · Jun 2012