510(k) · Cleared

Cleared

Readmyheart, Model RMH2.0

K052303510(k) TraditionalCleared Dec 16, 2005114-day reviewClass II21 CFR 870.2340

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dailycare Biomedical, Inc. · DPS Electrocardiograph

Cleared on Dec 16, 2005 as substantially equivalent to K042814 (Dailycare Biomedical, Inc., 2005) after a 114-day review. Its family tree reaches back 3 generations to 1997. 38 later devices descend from it.

Decided: Dec 16, 2005
Review: 114 days
Class: Class II
Product code: DPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K963725 (1997). 38 later devices descend from it, 3 citing it directly.

By dateBy generation

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 deviceK052303 Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
Descendant · cites it directly · 32 of its ownK111438 REKA E100Reka Pte, Ltd. · 2011
Descendant · 2 generations on · 31 of its ownK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
Descendant · 3 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
Descendant · 4 generations on · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled
Descendant · 5 generations on · 12 of its ownK181502 Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2011high 6 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 38 · See all

K111438REKA E100Reka Pte, Ltd. · 2011 · cites it directly32descendants
K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013 · 2 generations on31descendants
K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 3 generations on30descendants
K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · 4 generations on18descendants
K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018 · 5 generations on12descendants

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)	K052303	Readmyheart, Model RMH2.0	Dailycare Biomedical, Inc.	2005	—
+1	K111438	REKA E100	Reka Pte, Ltd.	2011	—
+2	K121628	Epi Mini Ecg Portable Health Monitoring System (Epi Mini)	Epi Mobile Health Solutions (S) Pte, Ltd.	2013	—
+3	K143513	ZIO SR ECG Monitoring Service	iRhythm Technologies, Inc.	2015	—
+4	K163512	Zio AT ECG Monitoring System	iRhythm Technologies, Inc.	2017	1
+5	K181502	Zio AT ECG Monitoring System, ZEUS System	iRhythm Technologies, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	2	0
2013	1	0
2015	1	0
2016	1	0
2017	3	0
2018	2	0
2019	2	0
2020	1	0
2021	1	0
2022	4	0
2023	3	0
2024	6	0
2025	4	0
2026	5	0

FIG. 1 — Lineage of K052303, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K042814	Readmyheart Summary page 1 …ectrocardiograph (per 21 CFR 870.2340) 3.0 Classification: Class li 4.0 Predicate Device: This predicate device is ReadMyHeart (k042814) marketed by DailyCare BioMedical Inc. 5.0 Intended Use:…	Dailycare Biomedical, Inc.	2005	—

Also cleared against K042814: 4 other devices →

What descends from it? (38)

See all 38

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K111438	REKA E100	Reka Pte, Ltd.	2011	32
K111159	Heartcheck Pen Handheld Ecg with Gems Home	Cardiocomm Solutions, Inc.	2011	2
K112622	Handheld Ecg Monitor	Beijing Choice Electronic Technololgy Co., Ltd.	2012	1

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, K111438 (Reka Pte, Ltd., 2011) has gone furthest, with 32 descendants of its own.
4 other devices also cite its predicate K042814.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DPS

6in 2025

2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007high 260 (2024) · low 31 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DPS

3in 2025

2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007high 121 (2011) · low 9 (2007)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?

ReadMyHeart OTC version is intended to record, store and transfer Lead I ECG signals, and display three ECG parameters for home health care use. The intended users are adults above 20 years old. This device is not intended to substitute for a hospital diagnostic ECG device. 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. The ReadMyHeart OTC version has simple software user interface without ECG trace viewing function.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052303 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052303: Readmyheart, Model RMH2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052303

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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