510(k) · Cleared
ClearedEpi Mini Ecg Portable Health Monitoring System (Epi Mini)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epi Mobile Health Solutions (S) Pte, Ltd. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jun 25, 2013 as substantially equivalent to K111438 (Reka Pte, Ltd., 2011) and 1 other predicate after a 386-day review. Its family tree reaches back 5 generations to 1997. 31 later devices descend from it.
- Decided
- Jun 25, 2013
- Review
- 386 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K963725 (1997). 12 ancestors in all, the oldest K963811 (1996). 31 later devices descend from it, 1 citing it directly.
- 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 backK111438 REKA E100Reka Pte, Ltd. · 2011
- This deviceK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
- Descendant · cites it directly · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
- Descendant · 2 generations on · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 12 of its ownK181502 Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018
- Descendant · 4 generations on · 6 of its ownK210822 DeepRhythmAIMedicalgorithmics S.A. · 2022
- Descendant · 4 generations on · 4 of its ownK190593 Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2019
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · cites it directly30descendants
- K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · 2 generations on18descendants
- K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018 · 3 generations on12descendants
- K210822DeepRhythmAIMedicalgorithmics S.A. · 2022 · 4 generations on6descendants
- K190593Zio XT ECG Monitoring System, Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2019 · 4 generations on4descendants
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 | K111438 | REKA E100 | Reka Pte, Ltd. | 2011 | — |
| 0 (this device) | K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013 | — |
| +1 | K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 | — |
| +2 | K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017 | 1 |
| +3 | K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | 2018 | — |
| +4 | K210822 | DeepRhythmAI | Medicalgorithmics S.A. | 2022 | — |
| +4 | K190593 | Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 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 |
|---|---|---|---|
| * | K111438 | REKA E100Summary page 2…Recorder Electrocardiograph, Telephone P2/4 D. Predicate Devices: * . Device Trade Name -~ | .510(k) No.: - | Classification Name | Product Code" REKA E100 ECG Event _ K111438 “Cardiovascular DPS Recorder (Cardiac Rhythm Monitoring Device Monitor) Signalife Fidelity 200 Cardiac K071228 Transmitter and Re… | 2011 |
| * | K071228 | Fidelity 200 Cardiac Event RecorderSummary page 2…Classification Name | Product Code" REKA E100 ECG Event _ K111438 “Cardiovascular DPS Recorder (Cardiac Rhythm Monitoring Device Monitor) Signalife Fidelity 200 Cardiac K071228 Transmitter and Receivers | DXH, DSH L. DEVICE DESCRIPTION: The EPI Mini ECG Portable Health Monitoring System (“EPI Mini”) is… | 2007 |
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143513 | ZIO SR ECG Monitoring Service | 2015 | 30 |
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 16 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K143513 (iRhythm Technologies, Inc., 2015) has gone furthest, with 30 descendants of its own.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The EPI Mini Portable ECG Recorder (“EPI Mini”) is intended for use with a patient’s smartphone to record, store and wirelessly transmit physiological data to a remote server. It is indicated for individuals who are at risk for cardiac disease, experience transient symptoms suggesting possible cardiac arrthythmia or have existing heart conditions. The device can function as an Rx product when prescribed by and used under the supervision of a physician…
Read the full statement (117 words)
The EPI Mini Portable ECG Recorder (“EPI Mini”) is intended for use with a patient’s smartphone to record, store and wirelessly transmit physiological data to a remote server. It is indicated for individuals who are at risk for cardiac disease, experience transient symptoms suggesting possible cardiac arrthythmia or have existing heart conditions.
The device can function as an Rx product when prescribed by and used under the supervision of a physician for the purpose of monitoring a patient’s ECG data. It is not a diagnostic device.
The EPI Mini is intended for use by adults who suffer from cardio-vascular disease, are considered high risk for possible cardiovascular events or are concemned about their heart function and rhythm.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121628 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121628: Epi Mini Ecg Portable Health Monitoring System (Epi Mini).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121628
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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