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Pregelled Disposable Electrode

by Vente Medical Products, Inc.

510(k) K781518

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781518 Date6 Oct 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a disposable electrocardiograph electrode (Classification name: Electrode, Electrocardiograph), designed for single-use attachment to the skin to record electrical activity of the heart. It features a pre-applied conductive gel to ensure consistent electrical contact and ease of application without additional preparation.

The electrode is supplied sterile and intended for use in cardiovascular diagnostic settings, adhering to FDA 510(k) clearance (K781518) under the Substantially Equivalent determination. It falls under CFR 870.2360 and is classified as a Class II medical device, requiring compliance with regulatory standards for electrocardiographic monitoring. Individual electrodes are packaged for single-use and must be discarded after use.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of this pre-gelled disposable electrode, and how does the pre-applied gel benefit the user?

    This pre-gelled disposable electrode is designed specifically for recording the heart’s electrical activity during electrocardiogram (ECG) tests. The pre-applied conductive gel ensures consistent electrical contact with the skin, eliminating the need for manual gel application. This simplifies the setup process, reduces preparation time, and helps maintain reliable signal quality for accurate diagnostic readings.

  • Are these electrodes intended for reuse, or must they be discarded after a single use? Why?

    These electrodes are explicitly designed for single-use only. The packaging is configured for individual use, and the manufacturer advises discarding them after one application to maintain sterility and prevent cross-contamination. Reuse could compromise signal accuracy and introduce infection risks.

  • How are these electrodes supplied, and what should I consider when storing them?

    The electrodes are supplied sterile in individual, single-use packages. They should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Check the packaging for expiration dates, as sterility may be compromised if stored improperly or past the indicated shelf life.

  • What regulatory pathway does this device follow, and which committee reviewed its submission?

    This device follows the FDA 510(k) clearance pathway, specifically under the Substantially Equivalent (SESE) determination (K781518). The submission was reviewed by the Cardiovascular (CV) Advisory Committee in 1978, as indicated by the product-code category DRX under CFR 870.2360. This classification ensures compliance with regulatory standards for electrocardiographic monitoring.