Cleared Traditional

AVELLE Negative Pressure Wound Therapy System (K180205) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180205 · Convatec Limited · General & Plastic Surgery device
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Oct 2018
Decision
268d
Days
Class 2
Risk

K180205 is an FDA 510(k) clearance for the AVELLE Negative Pressure Wound Therapy System. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Convatec Limited (Deeside, GB). The FDA issued a Cleared decision on October 19, 2018 after a review of 268 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.

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Submission Details

510(k) Number K180205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2018
Decision Date October 19, 2018
Days to Decision 268 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
153d slower than avg
Panel avg: 115d · This submission: 268d
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 92
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K180205.
RENASYS Y-Connector
K181204 · Smith & Nephew Medical Limited · Jan 2019
UNO Negative Pressure Wound Therapy System
K180840 · Genadyne Biotechnologies, Inc. · Nov 2018
Invia White Foam NPWT
K180415 · Medela AG · Nov 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
K180698 · Smith & Nephew Medical Limited · Aug 2018
VT - 100, VT - 200
K173407 · Carilex Medical, Inc. · Aug 2018
VT Dressing Kits
K172725 · Carilex Medical, Inc. · Jun 2018