510(k) · Cleared
ClearedMiCor A100 Wearable ECG Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitac International Corp. · DPS Electrocardiograph
Cleared on Jan 26, 2018 as substantially equivalent to K042814 (Dailycare Biomedical, Inc., 2005) after a 487-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Jan 26, 2018
- Review
- 487 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963725 (1997). No later device cites it as a predicate yet.
- 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 deviceK162665 MiCor A100 Wearable ECG RecorderMitac International Corp. · 2018
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) | K162665 | MiCor A100 Wearable ECG Recorder | Mitac International Corp. | 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 |
|---|---|---|---|
| * | K042814 | ReadmyheartSummary page 5…ation Number: 870.2340 Device Class: II Product Code: DPS 510(k) Number: K042814 2/8 MiTAC Internatio… | 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 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 3 ancestors has a recall.
- 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. 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?
The device is intended for use by users who have transient symptoms that may suggest cardiac conduction abnormalities or by users who wants to monitor the cardiac function at home health care from Lead 1 ECG signal.
ECG acquisition and transmission is voluntary and mutually activated by the user. The intend users are adult.
The device is design to let user wear on wrist and record ECG signal while user feel transient cardiac abnormalities symptoms any time.
Users with implanted pacemaker are not recommended to use this device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162665 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162665: MiCor A100 Wearable ECG Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162665
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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