510(k) · Cleared
ClearedInstantcheck RTD-Ecg Monitor, Model RMH4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dailycare Biomedical, Inc. · DPS Electrocardiograph
Cleared on Feb 8, 2007 as substantially equivalent to K042814 (Dailycare Biomedical, Inc., 2005) and 1 other predicate after a 134-day review. Its family tree reaches back 3 generations to 1997. 6 later devices descend from it.
- Decided
- Feb 8, 2007
- Review
- 134 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K963725 (1997). 5 ancestors in all. 6 later devices descend from it, 1 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 deviceK062894 Instantcheck RTD-Ecg Monitor, Model RMH4.0Dailycare Biomedical, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK150869 Checkme Pro Health MonitorViatom Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK191088 Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK242876 Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK213515 WesperO2Wesper, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK201635 MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health) · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K150869Checkme Pro Health MonitorViatom Technology Co., Ltd. · 2015 · cites it directly5descendants
- K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 2019 · 2 generations on2descendants
- K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd. · 2025 · 3 generations on0descendants
- K213515WesperO2Wesper, Inc. · 2022 · 3 generations on0descendants
- K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health) · 2021 · 2 generations on0descendants
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) | K062894 | Instantcheck RTD-Ecg Monitor, Model RMH4.0 | Dailycare Biomedical, Inc. | 2007 | — |
| +1 | K150869 | Checkme Pro Health Monitor | Viatom Technology Co., Ltd. | 2015 | — |
| +2 | K191088 | Checkme O2 Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 2019 | — |
| +3 | K242876 | Pulse Oximeter ( PO2, PO2A, PO2B) | Shenzhen Viatom Technology Co., Ltd. | 2025 | — |
| +3 | K213515 | WesperO2 | Wesper, Inc. | 2022 | — |
| +2 | K201635 | MouthLab Vital Signs Monitoring System | Multisensor Diagnostics (Dba Aidar Health) | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 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 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? (2)
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…Classification Name: Electrocardiograph (per 21 CFR 870.2340) 3.0 Classification: Class II 4.0 Predicate Device: ReadMyHeart (RMH2.0) (K042814) Omron HCG-801 Portable ECG Monitor (K060766) 5.0 Intended Use: The InstantCheck RTD-… | 2005 |
| * | K060766 | Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801Summary page 1…Classification: Class II 4.0 Predicate Device: ReadMyHeart (RMH2.0) (K042814) Omron HCG-801 Portable ECG Monitor (K060766) 5.0 Intended Use: The InstantCheck RTD-ECG monitor is a personal single lead electrocardiographic monitor whic… | 2006 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150869 | Checkme Pro Health Monitor | 2015 | 5 |
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 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K150869 (Viatom Technology Co., Ltd., 2015) 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. 2007, this device’s year, is highlighted.
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 InstantCheck RTD-ECG monitor is a personal single lead electrocardiographic monitor for recording and displaying real-time ECG data for home health care use. This device is intended for self-testing by adult users who might experience transient symptoms that may suggest cardiac conduction abnormity or by adult users whenever they want to have routine checks. ECG acquisition and transmission can be voluntarily and mutually activated by the adult users…
Read the full statement (150 words)
The InstantCheck RTD-ECG monitor is a personal single lead electrocardiographic monitor for recording and displaying real-time ECG data for home health care use. This device is intended for self-testing by adult users who might experience transient symptoms that may suggest cardiac conduction abnormity or by adult users whenever they want to have routine checks.
ECG acquisition and transmission can be voluntarily and mutually activated by the adult users for the purpose of healthcare management and reference for healthcare professionals.
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. The recorded data can be downloaded to Personal Computer via USB interface port.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062894 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062894: Instantcheck RTD-Ecg Monitor, Model RMH4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062894
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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