Not Cleared Direct

DEN180013 - PREVENA 125 and PREVENA PLUS 125 Therapy Units (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN180013 · Kci USA, Inc. · General & Plastic Surgery device
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Apr 2019
Decision
400d
Days
Class 2
Risk

DEN180013 is an FDA 510(k) submission (not cleared) for the PREVENA 125 and PREVENA PLUS 125 Therapy Units. Classified as Negative Pressure Wound Therapy Device For Reduction Of Wound Complications (product code QFC), Class II - Special Controls.

Submitted by Kci USA, Inc. (San Antonio, US). The FDA issued a Not Cleared (DENG) decision on April 19, 2019 after a review of 400 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4783 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 400 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Kci USA, Inc. devices

Submission Details

510(k) Number DEN180013 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 15, 2018
Decision Date April 19, 2019
Days to Decision 400 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
286d slower than avg
Panel avg: 114d · This submission: 400d
Pathway characteristics

Device Classification

Product Code QFC Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4783
Definition A Negative Pressure Wound Therapy Device For Reduction Of Wound Complications Is A Powered Suction Pump Intended For Wound Management And Reduction Of Wound Complications Via Application Of Negative Pressure To The Wound, Which Removes Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. This Device Type Is Intended For Use With Wound Dressings Classified Under 21 Cfr 878.4780. This Classification Does Not Include Devices Intended For Organ Space Wounds.
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.