# K972649: Cardiocall Cardiac Event Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Reynolds Medical, Ltd.
- Decided: Dec 4, 1997 after 142 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923930 (1992). 1 ancestor in all.
19 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923930: Electrocardiograph Transmitter, Tz Medical, Inc. (1992) Summary page 1.
- (no number) Ralin Heart-Aide Event recorder: named in the summary without a submission number

## Most influential descendants
- K063609: River- 1 Electrocardiograph (Ecg) Recorder and Transmitter (2007), 17 descendants of its own
- K080047: Cardiosen'c (2008), 11 descendants of its own
- K113514: Smartheart (2012), 10 descendants of its own
- K142476: Master Caution Device MCD (2015), 6 descendants of its own
- K161431: SimplECG (2016), 5 descendants of its own

## Recalls of this device
- Sep 3, 2015 · Class II · Z-0172-2016: 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

## Indications for use
The event recorder, called the “CardioCall,” is intended to be worn by the patient and to record a short period of electrocardiogram when the patient depresses a button upon sensing symptoms described to him by his physician. The CardioCall can either operate in the so-called “Looping” mode, in which it is always active, and in which it records a minute of one channel of cardiac activity before and a minute after the depression of the button; or in the “Post-Activation” mode, in which the device records two channels of cardiac activity for one minute after the depression of the record button. The PC computer program, called the “cardioConnect,” is indicated when it is desired to transfer the memory of the event recorder into a computer by direct connection, instead of using transtelephonic means. The CardioCall recorder is indicated if it is desired to record the electrocardiogram at the time when a patient experiences intermittent or transient symptoms such as dizziness, palpitations, or shortness of breath, and the patient is capable of activating the recorder at these times.

Source page: https://510kreport.com/device/K972649
Methodology: https://510kreport.com/methodology