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Accu-Trode (Disp. ECG Electrode)

by Warner/Chilcott

510(k) K771392

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 NumberK771392 Date16 Aug 1977ClearedStatusActive

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  • Withdrawn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, 22 Sep 2026

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

The Accu-Trode is an electrocardiograph electrode designed for use in cardiac monitoring. It functions by facilitating the electrical connection between the patient and an electrocardiograph device to capture heart activity.

This device is identified by FDA 510(k) number K771392 and is classified under regulation 870.2360. It is manufactured by Warner/Chilcott and has received FDA 510(k) clearance.

Questions

AI-generated answers, 22 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 function of the Accu-Trode?

    The Accu-Trode is an electrocardiograph electrode designed to facilitate the electrical connection between a patient and an electrocardiograph device. This connection allows for the capture and monitoring of heart activity.

  • Is the Accu-Trode intended for single-use or reuse?

    The device is identified as a disposable ECG electrode. This means it is intended for single-use applications to ensure proper signal quality and hygiene during cardiac monitoring procedures.

  • What is the regulatory status of this device?

    The Accu-Trode has received FDA 510(k) clearance under the number K771392. It is classified under regulation 870.2360 and was determined to be substantially equivalent to existing devices by the cardiovascular advisory committee.