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Vein Entry Indicator Device (VEID)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K993995

by Vascular Technologies , Ltd.

Identifiers

510(k) Number
K993995 FDA 510(k)
FDA Product Code
FMF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5860 FDA 510(k)
Regulation Number
880.5860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vein Entry Indicator Device (VEID) is a small plastic device designed to assist with peripheral intravenous cannulation. It utilizes a pressure sensor, signal indicator, and processing unit to provide an audible indication of the location of a vein during the insertion of an I.V. catheter system needle. The device specifically identifies vein entry, double puncture, re-entry, and exit events.

This device measures 20 by 21 by 25 mm and weighs 8.5 g. It has received FDA 510(k) clearance under K993995. Information regarding sterility, single-use status, or MRI safety is not provided.

Frequently asked questions

What is the primary function of the VEID?

The Vein Entry Indicator Device is designed to assist clinicians during peripheral intravenous cannulation. It uses an integrated pressure sensor and processing unit to provide an audible signal when the needle enters, exits, or re-enters a vein, as well as alerting the user to double puncture events.

What are the physical dimensions of this device?

The device is designed for portability and ease of use during procedures, measuring 20 by 21 by 25 mm. It is lightweight, weighing only 8.5 grams, which allows it to be integrated into the cannulation process without adding significant bulk.

What is the regulatory status of the VEID?

The Vein Entry Indicator Device has received FDA 510(k) clearance under K993995. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the General Hospital advisory committee category.

This description and any FAQs above were generated automatically from registry data 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. Sources consulted: VEID - Chelliah - 2000 - Anaesthesia - Wiley Online Library, VEIN ENTRY INDICATOR DEVICE (VEID) (K993995) - Innolitics, K993995 FDA 510 (k) - VEIN ENTRY INDICATOR DEVICE (VEID), VEIN ENTRY INDICATOR DEVICE (VEID) (K993995) - Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vascular Technologies , Ltd.

Sources (1)

  • FDA 510(k) K993995 24 fields · synced Sep 24, 2026