510(k) · Cleared
ClearedModel CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Card Guard, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Sep 10, 1997 after a 415-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 210 later devices descend from it.
- Decided
- Sep 10, 1997
- Review
- 415 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 0
210 later devices descend from it, 5 citing it directly.
- This deviceK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- Descendant · cites it directly · 181 of its ownK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- Descendant · 2 generations on · 99 of its ownK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- Descendant · cites it directly · 60 of its ownK012012 Ecg HomeH&C Medical Devices Spa · 2002
- Descendant · 2 generations on · 59 of its ownK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- Descendant · 2 generations on · 47 of its ownK052767 Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006
Showing 5 of 210 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 210 · See all- K012223CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001 · cites it directly181descendants
- K042254PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005 · 2 generations on99descendants
- K012012Ecg HomeH&C Medical Devices Spa · 2002 · cites it directly60descendants
- K042814ReadmyheartDailycare Biomedical, Inc. · 2005 · 2 generations on59descendants
- K052767Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006 · 2 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| +1 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| +2 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| +1 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| +2 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| +2 | K052767 | Afibalert Atrial Fibrillation Detector | Lechnologies Research, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 6 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 11 | 0 |
| 2014 | 9 | 0 |
| 2015 | 15 | 0 |
| 2016 | 9 | 0 |
| 2017 | 10 | 0 |
| 2018 | 11 | 0 |
| 2019 | 13 | 0 |
| 2020 | 13 | 0 |
| 2021 | 8 | 0 |
| 2022 | 12 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 13 | 0 |
| 2026 | 9 | 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? (210)
See all 2105 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012223 (Card Guard Scientific Survival, Ltd., 2001) has gone furthest, with 181 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?
This device intended for use by patients who experience transient symptoms that may suggest cardiac arthythmia.
The device is not intended for the simultaneous recording and transmitting of the patient’s ECQ signals.
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/K963725 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963725: Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963725
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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