510(k) · Cleared
ClearedReadmyheart
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dailycare Biomedical, Inc. · DPS Electrocardiograph
Cleared on Jan 6, 2005 as substantially equivalent to K012012 (H&C Medical Devices Spa, 2002) after an 86-day review. Its family tree reaches back 2 generations to 1997. 59 later devices descend from it.
- Decided
- Jan 6, 2005
- Review
- 86 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963725 (1997). 59 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 1 generation backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- This deviceK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- Descendant · cites it directly · 38 of its ownK052303 Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
- Descendant · 2 generations on · 32 of its ownK111438 REKA E100Reka Pte, Ltd. · 2011
- Descendant · 3 generations on · 31 of its ownK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
- Descendant · 4 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
- Descendant · 5 generations on · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K052303Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005 · cites it directly38descendants
- K111438REKA E100Reka Pte, Ltd. · 2011 · 2 generations on32descendants
- K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013 · 3 generations on31descendants
- K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 4 generations on30descendants
- K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · 5 generations on18descendants
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 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| 0 (this device) | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| +1 | K052303 | Readmyheart, Model RMH2.0 | Dailycare Biomedical, Inc. | 2005 | — |
| +2 | K111438 | REKA E100 | Reka Pte, Ltd. | 2011 | — |
| +3 | K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013 | — |
| +4 | K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 | — |
| +5 | K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K012012 | Ecg HomeSummary page 1…Handheld EGG monitor Classification name: Electrocardiograph 3,0 Classification: Class II 4.0 Predicate Device: The predicate device is the ecg~home(K012012 ) marketed by H&C MEDICAL DEVICES SPA. 5.0 Intended Use: ReadMyHeart is intended for use by us… | 2002 |
What descends from it? (59)
See all 595 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 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K052303 (Dailycare Biomedical, Inc., 2005) has gone furthest, with 38 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
The device is a personal single lead Electrocardiograph monitor. The device is intended for self-testing by patients by recording 15 seconds of the first standard lead I of 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 intended user are Users who are above 20 years old. The user is normally not required to apply electrode on…
Read the full statement (174 words)
The device is a personal single lead Electrocardiograph monitor. The device is intended for
self-testing by patients by recording 15 seconds of the first standard lead I of 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 intended user are Users who are
above 20 years old.
The user is normally not required to apply electrode on the body. Two electrodes integrated
within the device are provided. The user has to press his thumbs on the two electrodes in order
to record the ECG signal.
The User may also record ECG signals optionally through auxiliary external electrode provided
separately, if thumb pressings are inconvenient for any reason.
The recorded data can be downloaded to Personal Computer via USB interface port. This
device is not intended for use as precisely diagnostic tool. This device is also not intended for
recording and transmission of user's ECG signal simultaneously. Users with implanted
pacemaker are not recommended to use this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042814: Readmyheart.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042814
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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