510(k) · Cleared
ClearedCard Guard, Model CG-7100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Card Guard Scientific Survival, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jul 28, 1997 after a 241-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 100 later devices descend from it.
- Decided
- Jul 28, 1997
- Review
- 241 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
100 later devices descend from it, 1 citing it directly.
- This deviceK964836 Card Guard, Model CG-7100Card Guard Scientific Survival, Ltd. · 1997
- Descendant · cites it directly · 99 of its ownK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- Descendant · 2 generations on · 44 of its ownK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- Descendant · 2 generations on · 30 of its ownK122184 Ecg CheckCardiac Designs, LLC · 2013
- Descendant · 3 generations on · 28 of its ownK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 25 of its ownK071995 CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · Recalled
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 100 · See all- K042254PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005 · cites it directly99descendants
- K060911CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006 · 2 generations on44descendants
- K122184Ecg CheckCardiac Designs, LLC · 2013 · 2 generations on30descendants
- K140933Alivecor Heart MonitorAliveCor, Inc. · 2014 · 3 generations on28descendants
- K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964836 | Card Guard, Model CG-7100 | Card Guard Scientific Survival, Ltd. | 1997 | — |
| +1 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| +2 | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| +2 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| +3 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| +3 | K071995 | CG-6108 Continuous Ecg Monitor and Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 9 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (100)
See all 1001 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042254 | PMP4 Selfcheck Ecg | 2005 | 99 |
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?
- Of its descendants, K042254 (Card Guard Scientific Survival, Ltd., 2005) has gone furthest, with 99 descendants of its own.
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 CG-7100 Personal Electrocardiogram Telephone Transmitter is a patient activated cardiac event monitor for evaluation of transient symptoms. The CG-7100 allows a patient to record non-standard 12 leads electrocardiogram (ECG) in device memory and transmit the stored data to transtelephonic receiver located in physician office, hospital or cardiac monitoring center. This non-standard 12 leads electrocardiogram(ECG), which is measured with CG-7100…
Read the full statement (112 words)
The CG-7100 Personal Electrocardiogram Telephone Transmitter is a patient
activated cardiac event monitor for evaluation of transient symptoms.
The CG-7100 allows a patient to record non-standard 12 leads electrocardiogram
(ECG) in device memory and transmit the stored data to transtelephonic receiver
located in physician office, hospital or cardiac monitoring center.
This non-standard 12 leads electrocardiogram(ECG), which is measured with
CG-7100, should not be used for diagnostics in comparison to the standard 12
lead ECG obtained at standard electrode placement.
The CG-7100 is suggested to record and transmit ECG’s to physicians for use in
monitoring gross cardiac morphology changes in ambulatory patients for whom
physicians, in their judgment, believe cardiac monitoring is appropriate.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964836 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964836: Card Guard, Model CG-7100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964836
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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