Skip to content

Trauma-Trode ECG Electrode (597 Adhesive)

by Labeltape Meditect, Inc.

510(k) K874437

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 NumberK874437 Date30 Dec 1987ClearedStatusActive

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  • Withdrawn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, 1 Oct 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 an ECG electrode designed for use in cardiovascular monitoring applications. It is a trauma-trode type electrode with adhesive backing, intended for securing to the skin to detect electrical activity of the heart.

The electrode is supplied as a single-use adhesive unit, model 597 Adhesive, and is regulated under FDA 510(k) clearance K874437. It is classified as a Class II medical device with product code DRX, and was determined to be substantially equivalent to a predicate device upon clearance on December 30, 1987.

Other devices from Labeltape Meditect, Inc.

See all devices from Labeltape Meditect, Inc. →

Questions

AI-generated answers, 1 Oct 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 intended clinical use of the TRAUMA‑TRODE ECG electrode?

    It is designed to be applied to the patient’s skin to capture the heart’s electrical activity for cardiovascular monitoring. The adhesive backing ensures reliable contact during short‑term monitoring sessions.

  • How is the device supplied and is it reusable?

    The electrode is provided as a single‑use adhesive unit, identified as model 597 Adhesive. Because it is intended for one‑time application, it should be discarded after use to maintain performance and infection control.

  • What size or variations are available for this electrode?

    The product data lists only the 597 Adhesive version, so there are no additional sizes or model variations disclosed. Users should select this specific model for the intended monitoring application.

  • What regulatory pathway was used for this device?

    The TRAUMA‑TRODE ECG electrode received FDA 510(k) clearance (K874437) as a Class II device, classified under product code DRX. The clearance was based on a determination of substantial equivalence to a predicate device.