Cleared Traditional

K173447 - V.A.C.VIA 7 Day Therapy System Kit

K173447 is an FDA 510(k) clearance for V.A.C.VIA 7 Day Therapy System Kit, manufactured by Kci USA, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OMP cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K173447 · Kci USA, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
116d
Days
Class 2
Risk

K173447 is an FDA 510(k) clearance for the V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA .... 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 March 2, 2018 after a review of 116 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K173447

510(k) Number K173447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2017
Decision Date March 02, 2018
Days to Decision 116 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
1d slower than avg
Panel avg: 115d · This submission: 116d
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 135
Devices cleared under the same product code (OMP) and FDA review panel - the closest regulatory comparables to K173447.
PICO Single Use Negative Pressure Wound Therapy System
K180618 · Smith & Nephew Medical Limited · Apr 2018
PICO Single Use Negative Pressure Wound Therapy System
K180614 · Smith & Nephew Medical Limited · Apr 2018
PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
K173426 · Kci USA, Inc. · Mar 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
K172005 · Smith & Nephew Medical Limited · Feb 2018
Occlusion Detection Dressing Kit
K171499 · Cardinalhealth · Sep 2017
Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film
K170088 · Medela AG · Apr 2017