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 May 30, 2017 as substantially equivalent to K093872 (Beijing Choice Electronic Technololgy Co., Ltd., 2010) after a 60-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- May 30, 2017
- Review
- 60 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K992696 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK992696 Ecg Minimonitor, Model CG-5000Card Guard Scientific Survival, Ltd. · 1999
- 2 generations backK060766 Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801Omron Healthcare, Inc. · 2006
- 1 generation backK093872 Handheld Ecg Monitor, Model MD100Beijing Choice Electronic Technololgy Co., Ltd. · 2010
- This deviceK170954 Portable ECG MonitorContec Medical Systems Co.,Ltd · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K992696 | Ecg Minimonitor, Model CG-5000 | Card Guard Scientific Survival, Ltd. | 1999 | — |
| −2 | K060766 | Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801 | Omron Healthcare, Inc. | 2006 | — |
| −1 | K093872 | Handheld Ecg Monitor, Model MD100 | Beijing Choice Electronic Technololgy Co., Ltd. | 2010 | — |
| 0 (this device) | K170954 | Portable ECG Monitor | Contec Medical Systems Co.,Ltd | 2017 | — |
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 |
|---|---|---|---|
| * | K093872 | Handheld Ecg Monitor, Model MD100Summary page 6…K170954 Page 3 of 4 510(k) Number: K093872 Product Name: Handheld ECG Monitor Model Name: MD100 Non-Clinical Test Conclusion Non clinical tests were cond… | 2010 |
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 18 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K093872.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition. It is…
Read the full statement (131 words)
The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, which can detect, display and store ECG signal, and if possible, provide average heart rate message after ECG measurement. The users can use it themselves to check their heart condition.
It is suitable for the adult users, who suffers from cardiovascular diseases, or the adult people who are caring about their heart working conditions during their daily life. This device is not intended for use as a conventional diagnostic tool, but use as a healthcare tool which can provide doctor the recorded data as references.
The product is not a conventional diagnostic tool
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170954: Portable ECG Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170954
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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