510(k) · Cleared
Recalled · Class II · 2015Cardiocall Cardiac Event Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reynolds Medical, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Dec 4, 1997 as substantially equivalent to K923930 (Tz Medical, Inc., 1992) after a 142-day review. Its family tree reaches back 1 generation to 1992. 19 later devices descend from it. It has been recalled once.
- Decided
- Dec 4, 1997
- Review
- 142 days
- Class
- Class II
- Product code
- DXH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923930 (1992). 19 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923930 Electrocardiograph TransmitterTz Medical, Inc. · 1992
- This deviceK972649 Cardiocall Cardiac Event RecorderReynolds Medical, Ltd. · 1997
- Descendant · cites it directly · 17 of its ownK063609 River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd. · 2007
- Descendant · 2 generations on · 11 of its ownK080047 Cardiosen'cShl Telemedicine International, Ltd. · 2008
- Descendant · 3 generations on · 10 of its ownK113514 SmartheartShl Telemedicine International, Ltd. · 2012
- Descendant · 4 generations on · 6 of its ownK142476 Master Caution Device MCDHealthwatch, Ltd. · 2015
- Descendant · 5 generations on · 5 of its ownK161431 SimplECGNanowear, Inc. · 2016
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K063609River- 1 Electrocardiograph (Ecg) Recorder and TransmitterShl Telemedicine International, Ltd. · 2007 · cites it directly17descendants
- K080047Cardiosen'cShl Telemedicine International, Ltd. · 2008 · 2 generations on11descendants
- K113514SmartheartShl Telemedicine International, Ltd. · 2012 · 3 generations on10descendants
- K142476Master Caution Device MCDHealthwatch, Ltd. · 2015 · 4 generations on6descendants
- K161431SimplECGNanowear, Inc. · 2016 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923930 | Electrocardiograph Transmitter | Tz Medical, Inc. | 1992 | — |
| 0 (this device) | K972649 | Cardiocall Cardiac Event Recorder | Reynolds Medical, Ltd. | 1997 | — |
| +1 | K063609 | River- 1 Electrocardiograph (Ecg) Recorder and Transmitter | Shl Telemedicine International, Ltd. | 2007 | — |
| +2 | K080047 | Cardiosen'c | Shl Telemedicine International, Ltd. | 2008 | — |
| +3 | K113514 | Smartheart | Shl Telemedicine International, Ltd. | 2012 | — |
| +4 | K142476 | Master Caution Device MCD | Healthwatch, Ltd. | 2015 | — |
| +5 | K161431 | SimplECG | Nanowear, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K923930 | Electrocardiograph TransmitterSummary page 1…tters and Receivers, Electrocardiograph, Telephone (74DXH) (3) Equivalent legally-marketed devices: 1. Ralin Heart-Aide Event recorder 2. Braemar ER700 Event Recorder, K923930 (4) Description The CardioCall Event Recorder offers the user the choice of a looping cardiac event recorder (records the elect… | 1992 |
| * | — | Ralin Heart-Aide Event recorder Named without a submission number |
What descends from it? (19)
See all 192 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 3, 2015 | Class II | Z-0172-2016 | Vendor change control | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (177 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972649: Cardiocall Cardiac Event Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972649
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026