Cleared Traditional

K170088 - Invia Foam Dressing Kits with FitPad

K170088 is the FDA 510(k) clearance for Invia Foam Dressing Kits with FitPad by Medela AG. It is a Class 2 General & Plastic Surgery device (product code OMP) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K170088 · Medela AG · General & Plastic Surgery device
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Apr 2017
Decision
86d
Days
Class 2
Risk

K170088 is an FDA 510(k) clearance for the Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, I.... Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Medela AG (Baar, CH). The FDA issued a Cleared decision on April 6, 2017 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medela AG devices

Submission Details

510(k) Number K170088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2017
Decision Date April 06, 2017
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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 K170088.
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
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V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit
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PICO 7 Single Use Negative Pressure Wound Therapy System
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RENASYS GO
K152163 · Smith & Nephew, Inc. · Sep 2016
RENASYS-G Gauze Dressing Kits with Soft Port
K162129 · Smith & Nephew, Inc. · Aug 2016
RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device
K143133 · Smith & Nephew, Inc. · Jul 2015