510(k) · Cleared
ClearedPMP4 Selfcheck Ecg
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 Jan 13, 2005 as substantially equivalent to K012223 (Card Guard Scientific Survival, Ltd., 2001) and 1 other predicate after a 146-day review. Its family tree reaches back 2 generations to 1997. 99 later devices descend from it.
- Decided
- Jan 13, 2005
- Review
- 146 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963725 (1997). 4 ancestors in all, the oldest K964836 (1997). 99 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 1 generation backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- This deviceK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- Descendant · cites it directly · 44 of its ownK060911 CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006
- Descendant · cites it directly · 30 of its ownK122184 Ecg CheckCardiac Designs, LLC · 2013
- Descendant · 2 generations on · 28 of its ownK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 25 of its ownK071995 CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · Recalled
- Descendant · 3 generations on · 19 of its ownK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
Showing 5 of 99 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 99 · See all- K060911CG-6108 Arrhythmia Ecg Event RecorderCard Guard Scientific Survival, Ltd. · 2006 · cites it directly44descendants
- K122184Ecg CheckCardiac Designs, LLC · 2013 · cites it directly30descendants
- K140933Alivecor Heart MonitorAliveCor, Inc. · 2014 · 2 generations on28descendants
- K071995CG-6108 Continuous Ecg Monitor and Arrhythmia DetectorCard Guard Scientific Survival, Ltd. · 2007 · 2 generations on25descendants
- K142743AliveCor Heart MonitorAliveCor, Inc. · 2015 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| +1 | K060911 | CG-6108 Arrhythmia Ecg Event Recorder | Card Guard Scientific Survival, Ltd. | 2006 | — |
| +1 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| +2 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| +2 | K071995 | CG-6108 Continuous Ecg Monitor and Arrhythmia Detector | Card Guard Scientific Survival, Ltd. | 2007 | 2 |
| +3 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 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 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 |
|---|---|---|---|
| * | K012223 | CG-2211 Selfcheck Ecg TransmitterSummary page 6…01 CG-7100 12 Lead Personal ECG Transmitter K964836 Decision Date 07128197 PMP4 SelfCheckT" ECG is schematically identical to CG-2211 ECG Transmitter K012223, except it includes a 12 Lead option and uses the Bluetooth technology instead of transtelephonic transn~ission.It is also propos… | 2001 |
| * | K964836 | Card Guard, Model CG-7100Summary page 6…- CG-2211 1 Lead ECG Transmitter (OTC) KO12223 Decision Date 07/28/01 CG-7100 12 Lead Personal ECG Transmitter K964836 Decision Date 07128197 PMP4 SelfCheckT" ECG is schematically identical to CG-2211 ECG Transmitter K012223, except it includes a… | 1997 |
What descends from it? (99)
See all 997 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K060911 (Card Guard Scientific Survival, Ltd., 2006) has gone furthest, with 44 descendants of its own.
- 4 other devices also cite its predicate K012223.
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 PMP4 SelfCheckm ECG and Card Guard Heart Screening Service are intended for self-testing by patients and by health care professionals at home and at medical settings. This 12- lead and 1-lead electrocardiogram (ECG), allows remote patients tb display and transmit their ECG data to medical professionals via a communication device to a remote server.
Specifically, the PMP4 SelfCheckm ECG is intended for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms:
Skipped Beats
Pounding heart (Palpitations)
Heart Racing or Irregular Pulse
Lightheadedness or Faintness
History of Arrhythmias
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042254 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042254: PMP4 Selfcheck Ecg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042254
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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