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Vt - 100, Vt - 200

by Carilex Medical, Inc. United States 510(k)

510(k) K173407

Product code OMP

Overview

The VT-100 and VT-200 are negative pressure wound therapy powered suction pumps designed to provide wound therapy for patients. These devices are part of comprehensive negative pressure wound management systems and offer continuous and intermittent modes. The VT-100 is compatible with multiple wound sizes, while the VT-200 is purpose-built for complex wounds, including large or abdominal wounds when paired with the XL Dressing.

The VT-100 and VT-200 are supplied as medical devices with FDA 510(k) clearance under product code OMP. They are Class II devices regulated under number 878.4780. The devices are intended for use in general and plastic surgery applications. No information regarding sterility, single-use or reusable status, MRI safety, or storage conditions is provided in the device data.

Summary written by AI from registry data, 24 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK173407 Date9 Aug 2018ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
OMP
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What are the VT-100 and VT-200 devices used for?

    The VT-100 and VT-200 are negative pressure wound therapy powered suction pumps designed to provide wound therapy for patients. The VT-100 is compatible with multiple wound sizes, while the VT-200 is purpose-built for complex wounds, including large or abdominal wounds when paired with the XL Dressing.

  • What are the differences between the VT-100 and VT-200 models?

    The VT-100 is designed to be compatible with multiple wound sizes, making it versatile for various applications. The VT-200 is specifically purpose-built for complex wounds, particularly large or abdominal wounds when used with the XL Dressing, offering specialized treatment for more challenging cases.

  • What regulatory status do these devices have?

    The VT-100 and VT-200 are Class II medical devices with FDA 510(k) clearance under product code OMP, regulated under number 878.4780. They are intended for use in general and plastic surgery applications and have been determined to be substantially equivalent to predicate devices.

  • How are the VT-100 and VT-200 supplied?

    The devices are supplied as medical devices with FDA 510(k) clearance. No specific information regarding sterility status, whether they are single-use or reusable, MRI safety, or storage conditions is provided in the available device data.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K173407 24 fields · synced 22 Oct 2026