Cleared Traditional

K161897 - PREVENA DUO

K161897 is an FDA 510(k) clearance for PREVENA DUO, manufactured by Kci USA, Inc. (Kinetic Concepts, Inc.). The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K161897 · Kci USA, Inc. (Kinetic Concepts, Inc.) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
85d
Days
Class 2
Risk

K161897 is an FDA 510(k) clearance for the PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE D.... Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Kci USA, Inc. (Kinetic Concepts, Inc.) (San Antonio, US). The FDA issued a Cleared decision on October 4, 2016 after a review of 85 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 Kci USA, Inc. (Kinetic Concepts, Inc.) devices

FDA 510(k) Submission Details - K161897

510(k) Number K161897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2016
Decision Date October 04, 2016
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 136
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K161897.
Avance Foam Dressing Kit - XL
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RENASYS-G Gauze Dressing Kits with Soft Port
K162129 · Smith & Nephew, Inc. · Aug 2016
Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack
K153199 · Kci USA, Inc. · Feb 2016