510(k) · Cleared
ClearedReadmyheart, Model RMH3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dailycare Biomedical, Inc. · DPS Electrocardiograph
Cleared on Jul 14, 2005 as substantially equivalent to K042814 (Dailycare Biomedical, Inc., 2005) after a 126-day review. Its family tree reaches back 3 generations to 1997. 10 later devices descend from it.
- Decided
- Jul 14, 2005
- Review
- 126 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963725 (1997). 10 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 2 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 1 generation backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- This deviceK050620 Readmyheart, Model RMH3.0Dailycare Biomedical, Inc. · 2005
- Descendant · cites it directly · 5 of its ownK083229 E.S Teck ( Electro Sensor Teck)Ld Technology, LLC · 2009
- Descendant · 2 generations on · 4 of its ownK102442 E.S.O. (Electro Sensor Oxi)Ld Technology, LLC · 2010
- Descendant · 3 generations on · 2 of its ownK160956 LD-Oxi systemLd Technology, LLC · 2016
- Descendant · cites it directly · 2 of its ownK123130 Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation · 2013
- Descendant · 4 generations on · 1 of its ownK200141 Oxi-W SystemLd Technology, LLC · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K083229E.S Teck ( Electro Sensor Teck)Ld Technology, LLC · 2009 · cites it directly5descendants
- K102442E.S.O. (Electro Sensor Oxi)Ld Technology, LLC · 2010 · 2 generations on4descendants
- K160956LD-Oxi systemLd Technology, LLC · 2016 · 3 generations on2descendants
- K123130Answatch Wrist Monitor Model TS-0411Taiwan Scientific Corporation · 2013 · cites it directly2descendants
- K200141Oxi-W SystemLd Technology, LLC · 2020 · 4 generations on1descendant
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 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −1 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| 0 (this device) | K050620 | Readmyheart, Model RMH3.0 | Dailycare Biomedical, Inc. | 2005 | — |
| +1 | K083229 | E.S Teck ( Electro Sensor Teck) | Ld Technology, LLC | 2009 | — |
| +2 | K102442 | E.S.O. (Electro Sensor Oxi) | Ld Technology, LLC | 2010 | — |
| +3 | K160956 | LD-Oxi system | Ld Technology, LLC | 2016 | — |
| +1 | K123130 | Answatch Wrist Monitor Model TS-0411 | Taiwan Scientific Corporation | 2013 | — |
| +4 | K200141 | Oxi-W System | Ld Technology, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K042814 | ReadmyheartSummary page 1…Name: Electrocardiograph (per 21 CFR 870.2340) 3.0 Classification: Class II 4.0 Predicate Device: This predicate device is ReadMyHeart (RMH2.0, k042814) marketed by DailyCare BioMedical Inc. 5.0 Intended Use: The device is intended for… | 2005 |
What descends from it? (10)
3 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 3.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K083229 (Ld Technology, LLC, 2009) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K042814.
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 for home health care use. The device is intended for self-testing by users who might experience transient symptoms that may suggest cardiac conduction abnormity or by users whenever desired as routine recordings for daily home health care from Lead I ECG signal. ECG acquisition and transmission is voluntary and mutually activated by the user and the intended users are adults above 20 years…
Read the full statement (253 words)
The device is a personal single lead Electrocardiograph monitor for home health care use.
The device is intended for self-testing by users who might experience transient symptoms that may suggest cardiac conduction abnormity or by users whenever desired as routine recordings for daily home health care from Lead I ECG signal. ECG acquisition and transmission is voluntary and mutually activated by the user and the intended users are adults above 20 years old.
The user is normally not required to apply electrode on body. Two electrodes integrated within the device are provided. The user has to press his/her thumbs on the electrodes in order to record the ECG signal. The users may also record the signals optionally through auxiliary external electrode provided separately if thumb pressing is not convenient for reason. It is highly recommended to use auxiliary external electrode for HRV analysis.
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.
This device provides a parameter of heart rate variability (HRV) in RR interval which is only mathematical analysis and is not intended to produce any interpretation of those measurements or any kind of diagnosis. The device detects the appearance of irregular heart beat (IHB) during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050620 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050620: Readmyheart, Model RMH3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050620
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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