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Cardiocall Cardiac Event Recorder

by Reynolds Medical, Ltd.

510(k) K972649

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK972649 Date4 Dec 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0172-2016 FDA Class II initiated 3 Sep 2015

    When the battery is inserted into the CardioCall ECG Event Recorder, the device beeps twice and is followed by a continuous ringing sound that only stops when battery is removed. The device has a self-test failure and will not operate normally.

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  • Withdrawn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
DXH
FDA applicant
Reynolds Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Cardiocall Cardiac Event Recorder is a Class 2 cardiovascular device with product code DXH. It functions as a cardiac event recorder, designed to monitor and record cardiac events for diagnostic purposes.

The device is supplied by Reynolds Medical, Ltd. and was cleared through the Traditional 510(k) pathway on December 4, 1997, after a 142-day FDA review. It is authorized under FDA 510(k) number K972649 and is regulated under product code DXH for cardiovascular applications.

Other devices from Reynolds Medical, Ltd.

See all devices from Reynolds Medical, Ltd. →

Questions

AI-generated answers, 6 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 Cardiocall Cardiac Event Recorder used for?

    The Cardiocall Cardiac Event Recorder is a Class 2 cardiovascular device designed to monitor and record cardiac events for diagnostic purposes. It helps clinicians capture and analyze cardiac activity when symptoms occur.

  • How is the Cardiocall Cardiac Event Recorder supplied?

    The device is supplied by Reynolds Medical, Ltd. It is authorized under FDA 510(k) number K972649 and regulated under product code DXH for cardiovascular applications.

  • What is the regulatory status of the Cardiocall Cardiac Event Recorder?

    The Cardiocall Cardiac Event Recorder was cleared through the Traditional 510(k) pathway on December 4, 1997, after a 142-day FDA review. It is classified as a Class 2 cardiovascular device with product code DXH.

  • Is the Cardiocall Cardiac Event Recorder reusable or single-use?

    The device data does not specify whether the Cardiocall Cardiac Event Recorder is reusable or single-use. This information would be available in the product's instructions for use or from the manufacturer directly.