510(k) · Cleared
ClearedEcg Home
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H&C Medical Devices Spa · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jan 17, 2002 as substantially equivalent to K963725 (Card Guard, Ltd., 1997) after a 203-day review. Its family tree reaches back 1 generation to 1997. 60 later devices descend from it.
- Decided
- Jan 17, 2002
- Review
- 203 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963725 (1997). 60 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- This deviceK012012 Ecg HomeH&C Medical Devices Spa · 2002
- Descendant · cites it directly · 59 of its ownK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- Descendant · 2 generations on · 38 of its ownK052303 Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
- Descendant · 3 generations on · 32 of its ownK111438 REKA E100Reka Pte, Ltd. · 2011
- Descendant · 4 generations on · 31 of its ownK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
- Descendant · 5 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K042814ReadmyheartDailycare Biomedical, Inc. · 2005 · cites it directly59descendants
- K052303Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005 · 2 generations on38descendants
- K111438REKA E100Reka Pte, Ltd. · 2011 · 3 generations on32descendants
- K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013 · 4 generations on31descendants
- K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 5 generations on30descendants
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) | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| +1 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| +2 | K052303 | Readmyheart, Model RMH2.0 | Dailycare Biomedical, Inc. | 2005 | — |
| +3 | K111438 | REKA E100 | Reka Pte, Ltd. | 2011 | — |
| +4 | K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013 | — |
| +5 | K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified)Summary page 1…rketed device to which equivalence is being claimed is: Manufacturer Name | Applicant Name | Predicate Device 510(k) Number Card Guard Card Guard LTD | CG-2206 Personal K963725 "Scientific Survival ECG Transmitter LTD Table 5.7.1 reports a tchnical comparison between ecg@home device and CG-2206 Predicate… | 1997 |
What descends from it? (60)
See all 601 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042814 | Readmyheart | 2005 | 59 |
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?
ecg@home is a personal single lead ECG transtelephonic transmitter. The device is intended for self-testing by patients by recording ten seconds of the first standard lead (D1) or of the second standard lead (D2) of the electrocardiogram. The recording is activated by the patient when symptoms are experienced or whenever desired as routine recordings to be analyzed by a trained physician. The patient is normally not required to apply electrodes on the…
Read the full statement (169 words)
ecg@home is a personal single lead ECG transtelephonic transmitter. The device is intended for self-testing by patients by recording ten seconds of the first standard lead (D1) or of the second standard lead (D2) of the electrocardiogram. The recording is activated by the patient when symptoms are experienced or whenever desired as routine recordings to be analyzed by a trained physician.
The patient is normally not required to apply electrodes on the body. Two electrodes integrated within the device are provided. The patient has to place his thumbs on the two integrated electrodes in order to record the ECG signal.
In case of very low amplitude of lead D1 caused by heart orientation (mainly experienced by women), an external auxiliary electrode is provided in order to record lead D2.
The recorded data can be directly trasmitted to a receiving station via a common phone line or can be downloaded via RS 232 serial digital port to a Personal Computer for subsequent connection to a Service Provider using Internet facilities.
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/K012012 · printed Nov 3, 2026
Cite this page
510(k) Report. “K012012: Ecg Home.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K012012
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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