510(k) · Cleared
ClearedEcg Check
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Designs, LLC · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Feb 14, 2013 as substantially equivalent to K042254 (Card Guard Scientific Survival, Ltd., 2005) after a 206-day review. Its family tree reaches back 3 generations to 1997. 30 later devices descend from it.
- Decided
- Feb 14, 2013
- Review
- 206 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963725 (1997). 5 ancestors in all, the oldest K964836 (1997). 30 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 2 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 1 generation backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- This deviceK122184 Ecg CheckCardiac Designs, LLC · 2013
- Descendant · cites it directly · 28 of its ownK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 19 of its ownK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- Descendant · 3 generations on · 12 of its ownK171816 Kardia Band SystemAliveCor, Inc. · 2017
- Descendant · 2 generations on · 6 of its ownK201456 Scan MonitorWithings SA · 2021 · Recalled
- Descendant · 4 generations on · 6 of its ownK181823 KardiaAIAliveCor, Inc. · 2019
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K140933Alivecor Heart MonitorAliveCor, Inc. · 2014 · cites it directly28descendants
- K142743AliveCor Heart MonitorAliveCor, Inc. · 2015 · 2 generations on19descendants
- K171816Kardia Band SystemAliveCor, Inc. · 2017 · 3 generations on12descendants
- K201456Scan MonitorWithings SA · 2021 · 2 generations on6descendants
- K181823KardiaAIAliveCor, Inc. · 2019 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −2 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −1 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| 0 (this device) | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| +1 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| +2 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| +3 | K171816 | Kardia Band System | AliveCor, Inc. | 2017 | — |
| +2 | K201456 | Scan Monitor | Withings SA | 2021 | 1 |
| +4 | K181823 | KardiaAI | AliveCor, Inc. | 2019 | — |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K042254 | PMP4 Selfcheck EcgSummary page 1…e electrocardiograph transmitter and receiver, Product Code DXH Legally Marketed Predicate PMP4 SelfCheck TM EGG (K042254), manufactured by Card Device: Guard Scientific Survival, Ltd. Description of New ECG CHECK Device:. The EGG Check… | 2005 |
What descends from it? (30)
See all 302 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 16 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K140933 (AliveCor, Inc., 2014) has gone furthest, with 28 descendants of its own.
- 6 other devices also cite its predicate K042254.
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. 2013, 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 ECG Check is intended for self-testing by patients at home. This 1-lead cardiac monitor allows remote patients to display and transmit their EGG data to medical professionals via a communication device to a remote server.
Specifically, the EGG Check is indicated 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/K122184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122184: Ecg Check.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122184
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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