510(k) · Cleared
ClearedeCordum Cardiac Monitor (eCordum CM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ecordum, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Oct 30, 2020 as substantially equivalent to K121197 (Preventice, Inc., 2012) after a 338-day review. Its family tree reaches back 7 generations to 1988. 3 later devices descend from it.
- Decided
- Oct 30, 2020
- Review
- 338 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K882803 (1988). 12 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 6 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 5 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 4 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 3 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 2 generations backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- 1 generation backK121197 Bodyguardian System Bodyguardian Control Unit Bodyguardian ConnectPreventice, Inc. · 2012
- This deviceK193296 eCordum Cardiac Monitor (eCordum CM)Ecordum, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK222842 V-Patch Cardiac MonitorShandong Corecare Technology Limited · 2022
- Descendant · 2 generations on · 0 of its ownK243438 MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243003 VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K222842V-Patch Cardiac MonitorShandong Corecare Technology Limited · 2022 · cites it directly1descendant
- K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd. · 2025 · 2 generations on0descendants
- K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −6 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −5 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −4 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −3 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −2 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| −1 | K121197 | Bodyguardian System Bodyguardian Control Unit Bodyguardian Connect | Preventice, Inc. | 2012 | — |
| 0 (this device) | K193296 | eCordum Cardiac Monitor (eCordum CM) | Ecordum, Inc. | 2020 | — |
| +1 | K222842 | V-Patch Cardiac Monitor | Shandong Corecare Technology Limited | 2022 | — |
| +2 | K243438 | MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. | 2025 | — |
| +1 | K243003 | VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K121197 | Bodyguardian System Bodyguardian Control Unit Bodyguardian ConnectSummary page 4…Codes: DXH Device Class: II Classification Panel: Cardiovascular 5. Legally Marketed Predicate Device(s) K121197 BodyGuardian System manufactured by Preventice Solutions 6. Device Description The eCordum™ Cardiac Monitor (eCordum™ CM) i… | 2012 |
What descends from it? (3)
2 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 32 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K222842 (Shandong Corecare Technology Limited, 2022) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K121197.
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. 2020, 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 eCordumTm Cardiac Monitor is intended to record, transfer and store single-channel electrocardiogram (ECG) data via Bluetooth transmission to Bluetooth enabled devices. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193296: eCordum Cardiac Monitor (eCordum CM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193296
Report an extraction error
Are you the manufacturer?
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