510(k) · Cleared
ClearedHeartCheck Cardi Beat ECG Monitor with GEMS Mobile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiocomm Solutions, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Feb 22, 2019 as substantially equivalent to K111159 (Cardiocomm Solutions, Inc., 2011) after a 281-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Feb 22, 2019
- Review
- 281 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K963725 (1997). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 4 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 3 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 2 generations backK052303 Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
- 1 generation backK111159 Heartcheck Pen Handheld Ecg with Gems HomeCardiocomm Solutions, Inc. · 2011
- This deviceK181310 HeartCheck Cardi Beat ECG Monitor with GEMS MobileCardiocomm Solutions, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −4 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −3 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −2 | K052303 | Readmyheart, Model RMH2.0 | Dailycare Biomedical, Inc. | 2005 | — |
| −1 | K111159 | Heartcheck Pen Handheld Ecg with Gems Home | Cardiocomm Solutions, Inc. | 2011 | — |
| 0 (this device) | K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS Mobile | Cardiocomm Solutions, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 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? (1)
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 |
|---|---|---|---|
| * | K111159 | Heartcheck Pen Handheld Ecg with Gems HomeSummary page 6…Class II Product Code: DXH Regulations: 870.2920 SE Predicate Device(s): HeartCheck™ ECG PEN K111159 SE Reference Device(s): ECG Check K122184 1.1 Device Description The HeartCheck™ CardiBeat ECG Monitor devi… | 2011 |
| † | K122184 | Ecg Check | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K111159.
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. 2019, this device’s year, is highlighted.
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 HeartCheck™ Cardi Beat ECG Monitor device with the GEMS Mobile software is an over-the-counter device to be used by patients 21 years of age or older. It is intended to record, store and transfer single channel Heart Rhythm signals and display Heart Rhythm waveforms. This 1-lead cardiac monitor allows remote users to display and transmit their ECG data to medical professionals via a communication device to a remote server. The HeartCheck™ Cardi Beat…
Read the full statement (193 words)
The HeartCheck™ Cardi Beat ECG Monitor device with the GEMS Mobile software is an over-the-counter device to be used by patients 21 years of age or older. It is intended to record, store and transfer single channel Heart Rhythm signals and display Heart Rhythm waveforms. This 1-lead cardiac monitor allows remote users to display and transmit their ECG data to medical professionals via a communication device to a remote server.
The HeartCheck™ Cardi Beat ECG Monitor combined with GEMS Mobile software is indicated for users who are concerned about their heart rhythms and may have experienced symptoms that may suggest irregular or abnormal heart rhythms. Symptoms may include:
• Skipped beats
• Palpitations
• Racing heart
• Fainting and lightheadedness
• Irregular rate
• History of any related heart abnormalities
The HeartCheck™ Cardi Beat ECG Monitor along with the GEMS Mobile software is not intended to substitute a hospital diagnostic ECG device. Users with an implanted pacemaker or are not recommended to use this device while the implanted device is operational. Users where their pacemaker is operational will not be able to record their ECG under normal sinus rhythm with the pacemaker on.
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/K181310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181310: HeartCheck Cardi Beat ECG Monitor with GEMS Mobile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181310
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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