510(k) · Cleared
ClearedHandheld Ecg Monitor, Model MD100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Choice Electronic Technololgy Co., Ltd. · DPS Electrocardiograph
Cleared on Mar 31, 2010 as substantially equivalent to K060766 (Omron Healthcare, Inc., 2006) after a 104-day review. Its family tree reaches back 2 generations to 1999. 37 later devices descend from it.
- Decided
- Mar 31, 2010
- Review
- 104 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992696 (1999). 37 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK992696 Ecg Minimonitor, Model CG-5000Card Guard Scientific Survival, Ltd. · 1999
- 1 generation backK060766 Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801Omron Healthcare, Inc. · 2006
- This deviceK093872 Handheld Ecg Monitor, Model MD100Beijing Choice Electronic Technololgy Co., Ltd. · 2010
- Descendant · cites it directly · 32 of its ownK111438 REKA E100Reka Pte, Ltd. · 2011
- Descendant · 2 generations on · 31 of its ownK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
- Descendant · 3 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
- Descendant · 4 generations on · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled
- Descendant · 5 generations on · 12 of its ownK181502 Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K111438REKA E100Reka Pte, Ltd. · 2011 · cites it directly32descendants
- K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013 · 2 generations on31descendants
- K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 3 generations on30descendants
- K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · 4 generations on18descendants
- K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992696 | Ecg Minimonitor, Model CG-5000 | Card Guard Scientific Survival, Ltd. | 1999 | — |
| −1 | K060766 | Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801 | Omron Healthcare, Inc. | 2006 | — |
| 0 (this device) | K093872 | Handheld Ecg Monitor, Model MD100 | Beijing Choice Electronic Technololgy Co., Ltd. | 2010 | — |
| +1 | K111438 | REKA E100 | Reka Pte, Ltd. | 2011 | — |
| +2 | K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013 | — |
| +3 | K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 | — |
| +4 | K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017 | 1 |
| +5 | K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K060766 | Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801Summary page 1…tor MD100 Common Name: Handheld, ECG Monitor Classification: 21 CFR 870.2340 Oximeter Class: II 3. Legally Marketed Predicate Device Omron HCG-801 Portable ECG Monitor K0 60 76 6 Omron Healthcare, Inc. Premarket Notification 510(k) Submission - Chapter III 510(k) Summary Report No.: TE20… | 2006 |
What descends from it? (37)
See all 374 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K111438 (Reka Pte, Ltd., 2011) has gone furthest, with 32 descendants of its own.
- 10 other devices also cite its predicate K060766.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 hospital. or home health care use, which can detect, display and store EGG signal, and if possible, provide average heart rate message after ECG measurement. The users can uise it themselves to check their heart condition.…
Read the full statement (133 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 hospital. or home health care use, which can detect, display and store EGG signal, and if possible, provide average heart rate message after ECG measurement. The users can uise it themselves to check their heart condition.
It is suitable for the adult users, who suffers from cardio-vascular 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/K093872 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093872: Handheld Ecg Monitor, Model MD100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093872
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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