510(k) · Cleared
ClearedCG-2211 Selfcheck Ecg Transmitter
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 Sep 10, 2001 as substantially equivalent to K963725 (Card Guard, Ltd., 1997) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1997. 181 later devices descend from it.
- Decided
- Sep 10, 2001
- Review
- 56 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963725 (1997). 2 ancestors in all. 181 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- This deviceK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- Descendant · cites it directly · 99 of its ownK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- Descendant · cites it directly · 47 of its ownK052767 Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006
- Descendant · 2 generations on · 44 of its ownK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- Descendant · cites it directly · 32 of its ownK071228 Fidelity 200 Cardiac Event RecorderSignalife, Inc. · 2007
- Descendant · 2 generations on · 31 of its ownK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
Showing 5 of 181 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 181 · See all- K042254PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005 · cites it directly99descendants
- K052767Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006 · cites it directly47descendants
- K060911CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006 · 2 generations on44descendants
- K071228Fidelity 200 Cardiac Event RecorderSignalife, Inc. · 2007 · cites it directly32descendants
- K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013 · 2 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| 0 (this device) | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| +1 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| +1 | K052767 | Afibalert Atrial Fibrillation Detector | Lechnologies Research, Inc. | 2006 | — |
| +2 | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| +1 | K071228 | Fidelity 200 Cardiac Event Recorder | Signalife, Inc. | 2007 | — |
| +2 | K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 9 | 0 |
| 2014 | 9 | 0 |
| 2015 | 14 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 9 | 0 |
| 2019 | 10 | 0 |
| 2020 | 12 | 0 |
| 2021 | 7 | 0 |
| 2022 | 10 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 12 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified)Summary page 3…transmitter. Said clearance is hereby sought on the grounds that the CG-2211 is substantially equivalent to the following predicate devices: 1. CG-2206 ECG Transmitter K963725 2. HeartCard® Telephone Electrocardiograph Transmitter and Receiver K010945 The CG-2206 ECG Transmitter was cleared for sale in… | 1997 |
| * | K010945 | Heartcard, Model 5258Summary page 3…is substantially equivalent to the following predicate devices: 1. CG-2206 ECG Transmitter K963725 2. HeartCard® Telephone Electrocardiograph Transmitter and Receiver K010945 The CG-2206 ECG Transmitter was cleared for sale in the US in September 10, 1997 as a prescription device (tracking number K963 7… | 2001 |
What descends from it? (181)
See all 1815 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?
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-2211 SelfCheck ECG Transmitter and LifeWatch Heart Screening Service are intended for self-testing by patients who are concerned about their heart rhythm (i.e. during or after exercise) or who experience the following symptoms that are suggestive of abnormal heart rhythms, and who would like to monitor these symptoms: Skipped Beats Pounding heart (Palpitations) Heart Racing or Irregular Pulse Lightheadedness or Faintness History of Arrhythmias…
Read the full statement (363 words)
The CG-2211 SelfCheck ECG Transmitter and LifeWatch Heart Screening Service are intended for self-testing by patients who are concerned about their heart rhythm (i.e. during or after exercise) or who experience the following symptoms that are suggestive of abnormal heart rhythms, and who would like to monitor these symptoms:
Skipped Beats
Pounding heart (Palpitations)
Heart Racing or Irregular Pulse
Lightheadedness or Faintness
History of Arrhythmias
Contraindications for Use:
In order to use this service, the patient must be able to perform all of the following:
Read and understand the User’s Manual
Place the HeartCard on his/her chest and hold it steadily for at least 30 seconds.
Hear the “beeps” for low battery.
Speak and understand English.
Operate a telephone.
Operate a simple, push-button device.
Due to the possible seriousness of the abnormal heart rhythms that can be associated with these conditions, persons who have been diagnosed with the following conditions should consult their physician before using this service:
Blockage of the arteries of the heart
Heart valve problems
Heart transplant
Congestive heart failure
Loss of consciousness
If the patient has any of these conditions, LifeWatch will need to obtain authorization from their physician within 35 days of enrollment in the service.
Warning:
This device is not designed to be used with pacemakers or defibrillators. If the patient has either of these, the patient will not be allowed to enroll in the service.
This device also cannot predict or diagnose a heart attack or be used for chest pain monitoring.
Need for Signed Physician Agreement:
Your agreement indicates you understand that LifeWatch (or affiliate) will contact your physician to verify in writing that you are their patient and that they are willing to be contacted in cases where there are clinically significant events involving your care.
Your agreement indicates you understand that if written verification is not received from your physician within 35 days of your enrollment, you will not be able to utilize any aspects of the LifeWatch (or affiliate) service until such verification is received by LifeWatch (or affiliate).
Your agreement certifies you understand that this service is not a substitute for physician care and that this is only a screening service.
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/K012223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012223: CG-2211 Selfcheck Ecg Transmitter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012223
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026