Cleared Traditional

K181507 - PREVENA RESTOR(TM) Incision Management ...

K181507 is the FDA 510(k) clearance for PREVENA RESTOR(TM) Incision Management ... by Kci USA, Inc.. It is a Class 2 General & Plastic Surgery device (product code OMP) cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K181507 · Kci USA, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
253d
Days
Class 2
Risk

K181507 is an FDA 510(k) clearance for the PREVENA RESTOR(TM) Incision Management System. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Kci USA, Inc. (San Antonio, US). The FDA issued a Cleared decision on February 15, 2019 after a review of 253 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 Kci USA, Inc. devices

Submission Details

510(k) Number K181507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2018
Decision Date February 15, 2019
Days to Decision 253 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 115d · This submission: 253d
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 100
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K181507.
MiMo(TM) Negative Pressure Wound Therapy System
K181929 · Baymax Research, Inc. · Mar 2019
RENASYS Touch
K181822 · Smith & Nephew Medical Limited · Mar 2019
ACTIV.A.C. Therapy Unit
K183543 · Kci USA, Inc. · Mar 2019
Invia Abdominal Dressing Kit
K182191 · Medela AG · Feb 2019
PICO 7Y Single Use Negative Pressure Wound Therapy System
K182323 · Smith & Nephew Medical Limited · Jan 2019
Applied Tissue Technologies PWD™ Platform Wound Dressing
K182409 · Applied Tissue Technologies, LLC · Jan 2019