510(k) · Cleared
ClearedEcg Pen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Dynamics Biomedical, Inc. · DPS Electrocardiograph
Cleared on Jul 13, 2011 as substantially equivalent to K060766 (Omron Healthcare, Inc., 2006) and 1 other predicate after a 268-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jul 13, 2011
- Review
- 268 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
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 backK080933 Handheld Ecg Monitor, Model MD100Beijing Choice Electronic Technololgy Co., Ltd. · 2008
- This deviceK103077 Ecg PenMeridian Dynamics Biomedical, Inc. · 2011
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 | K080933 | Handheld Ecg Monitor, Model MD100 | Beijing Choice Electronic Technololgy Co., Ltd. | 2008 | — |
| 0 (this device) | K103077 | Ecg Pen | Meridian Dynamics Biomedical, Inc. | 2011 | — |
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? (2)
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…ct Code: DPS Regulation No.: 21CFR870.2340 4.0 Predicate Device: The predicate device is the Omron HCG-801 portable ECG Monitor (K060766) marketed by Omron Healthcare, Inc. & MD100 Handheld ECG Monitor (K080933) marketed by… | 2006 |
| * | K080933 | Handheld Ecg Monitor, Model MD100Summary page 1…vice is the Omron HCG-801 portable ECG Monitor (K060766) marketed by Omron Healthcare, Inc. & MD100 Handheld ECG Monitor (K080933) marketed by Beijing Choice Electronic Technology Co., Ltd.. 5.0 Intended Use: The Vion.ECG Pen (M… | 2008 |
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 12 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 ancestors has a recall.
- 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. 2011, 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 Vion.ECG Pen (Model no.: 8OOE) is intended for recording EGG data and displaying general information by adult patients who are concerned their heart rhythm and waveform. This Vion.ECG Pen allows the patients to record transient cardiac events voluntarily for providing to the healthcare professionals as references during office visits.
In addition, the patient can also record their EGG data and transmit the recorded data to personal computer.
The Vion.ECG Pen is not intended for recording and transmission of user's EGG signal simultaneously. Users with implanted pacemakers are not recommended to use this device. This device is not intended to substitute a conventional diagnostic tool.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103077: Ecg Pen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103077
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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