Cleared Traditional

VT - 100, VT - 200 (K173407) - FDA 510(k) Clearance

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

K173407 · Carilex Medical, Inc. · General & Plastic Surgery device
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Aug 2018
Decision
281d
Days
Class 2
Risk

K173407 is an FDA 510(k) clearance for the VT - 100, VT - 200. Classified as Negative Pressure Wound Therapy Powered Suction Pump (product code OMP), Class II - Special Controls.

Submitted by Carilex Medical, Inc. (Taoyuan City, TW). The FDA issued a Cleared decision on August 9, 2018 after a review of 281 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 Carilex Medical, Inc. devices

Submission Details

510(k) Number K173407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2017
Decision Date August 09, 2018
Days to Decision 281 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
166d slower than avg
Panel avg: 115d · This submission: 281d
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 K173407.
Invia White Foam NPWT
K180415 · Medela AG · Nov 2018
AVELLE Negative Pressure Wound Therapy System
K180205 · Convatec Limited · Oct 2018
PICO 7 Single Use Negative Pressure Wound Therapy System
K180698 · Smith & Nephew Medical Limited · Aug 2018
VT Dressing Kits
K172725 · Carilex Medical, Inc. · Jun 2018
Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
K180855 · Kci USA, Inc. · Jun 2018
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
K172145 · Medela AG · May 2018