Cleared Traditional

K080357 - MEDELA INVIA WOUND THERAPY

K080357 is the FDA 510(k) clearance for MEDELA INVIA WOUND THERAPY by Medela AG. It is a Class 2 General & Plastic Surgery device (product code OMP) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K080357 · Medela AG · General & Plastic Surgery device
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Jul 2008
Decision
164d
Days
Class 2
Risk

K080357 is an FDA 510(k) clearance for the MEDELA INVIA WOUND THERAPY. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Medela AG (Baar Zug, CH). The FDA issued a Cleared decision on July 24, 2008 after a review of 164 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 K080357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2008
Decision Date July 24, 2008
Days to Decision 164 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
49d slower than avg
Panel avg: 115d · This submission: 164d
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 K080357.
RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
K083375 · Smith & Nephew, Inc. · Feb 2009
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
K082211 · Smith & Nephew, Inc. · Nov 2008
RENASYS EZ
K082426 · Smith & Nephew, Inc. · Sep 2008
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K061788 · Boehringer Laboratories · Jul 2006
V.A.C. GRANUFOAM SILVER PROTECTION DRESSING
K050261 · Kinetic Concepts, Inc. · May 2005
V.A.C. GRANUFOAM SILVER DRESSING
K041642 · Kinetic Concepts, Inc. · Jan 2005