510(k) · Cleared
ClearedCheckMyHeart Plus
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 5, 2018 as substantially equivalent to K050620 (Dailycare Biomedical, Inc., 2005) after a 294-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Jul 5, 2018
- Review
- 294 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K963725 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 3 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 2 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 1 generation backK050620 Readmyheart, Model RMH3.0Dailycare Biomedical, Inc. · 2005
- This deviceK172778 CheckMyHeart PlusDailycare Biomedical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −3 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −2 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −1 | K050620 | Readmyheart, Model RMH3.0 | Dailycare Biomedical, Inc. | 2005 | — |
| 0 (this device) | K172778 | CheckMyHeart Plus | Dailycare Biomedical, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K050620 | Readmyheart, Model RMH3.0Summary page 4…s: II Product Code: DPS Review Panel: Cardiovascular 3. PREDICATE READMYHEART, MODEL RMH3.0, K050620 DEVICE 4. DEVICE CheckMyHeart Plus is intended to record, recall, store and DESCRIPTION… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K050620.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
CheckMyHeart Plus is intended to record, recall, store and transfer Lead I ECG signals for home health care use. The intended users are adults above 21 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 signals simultaneously.
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/K172778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172778: CheckMyHeart Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172778
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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