510(k) · Cleared
ClearedPortable ECG Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contec Medical Systems Co.,Ltd · DPS Electrocardiograph
Cleared on Jun 22, 2016 as substantially equivalent to K112622 (Beijing Choice Electronic Technololgy Co., Ltd., 2012) after a 266-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Jun 22, 2016
- Review
- 266 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K963725 (1997). No later device cites it as a predicate yet.
- Root · 5 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 4 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 3 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 2 generations backK052303 Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
- 1 generation backK112622 Handheld Ecg MonitorBeijing Choice Electronic Technololgy Co., Ltd. · 2012
- This deviceK152863 Portable ECG MonitorContec Medical Systems Co.,Ltd · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −4 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −3 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −2 | K052303 | Readmyheart, Model RMH2.0 | Dailycare Biomedical, Inc. | 2005 | — |
| −1 | K112622 | Handheld Ecg Monitor | Beijing Choice Electronic Technololgy Co., Ltd. | 2012 | — |
| 0 (this device) | K152863 | Portable ECG Monitor | Contec Medical Systems Co.,Ltd | 2016 | — |
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 |
|---|---|---|---|
| * | K112622 | Handheld Ecg MonitorSummary page 5…C and mobile phone includes sample mode and time setting, upload case, case review, measurement etc. 5. Identification of Predicate Device 510(k) Number: K112622 Product Name: Handheld ECG Monitor Model Name: MD100A1-F 6. Non-Clinical Test Conclusion Non clinical tests… | 2012 |
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 19 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Portable ECG Monitor PM10 is intended to record and store Lead I ECG signals, and display heart rate 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. Users with implanted pacemaker are not recommended to use this device. The Portable ECG Monitor PM10 has simple user interface without ECG trace viewing function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152863 · printed Nov 4, 2026
Cite this page
510(k) Report. “K152863: Portable ECG Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K152863
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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