510(k) · Cleared
ClearedTelaheart Digital Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North East Monitoring, Inc. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Aug 25, 2006 as substantially equivalent to K041901 (North East Monitoring, Inc., 2004) and 1 other predicate after a 108-day review. Its family tree reaches back 3 generations to 1992. 5 later devices descend from it.
- Decided
- Aug 25, 2006
- Review
- 108 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K923930 (1992). 7 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK923930 Electrocardiograph TransmitterTz Medical, Inc. · 1992
- 2 generations backK981394 Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Braemar Corp. · 1998
- 1 generation backK030856 ER800 Series Ecg Event RecorderBraemar Corp. · 2003
- This deviceK061293 Telaheart Digital RecorderNorth East Monitoring, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK142424 DR300 Holter MonitorNorth East Monitoring, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK151787 Holter SystemEdan Instruments, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK254119 Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK070014 Auto Detect for Telaheart DR200/E-aNorth East Monitoring, Inc. · 2007
Most influential descendants
Showing 5 of 5 · See all- K142424DR300 Holter MonitorNorth East Monitoring, Inc. · 2014 · cites it directly3descendants
- K151787Holter SystemEdan Instruments, Inc. · 2016 · 2 generations on2descendants
- K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026 · 3 generations on0descendants
- K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026 · 3 generations on0descendants
- K070014Auto Detect for Telaheart DR200/E-aNorth East Monitoring, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923930 | Electrocardiograph Transmitter | Tz Medical, Inc. | 1992 | — |
| −2 | K981394 | Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720 | Braemar Corp. | 1998 | — |
| −1 | K030856 | ER800 Series Ecg Event Recorder | Braemar Corp. | 2003 | — |
| 0 (this device) | K061293 | Telaheart Digital Recorder | North East Monitoring, Inc. | 2006 | — |
| +1 | K142424 | DR300 Holter Monitor | North East Monitoring, Inc. | 2014 | — |
| +2 | K151787 | Holter System | Edan Instruments, Inc. | 2016 | — |
| +3 | K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart… | Shenzhen Xinyan Medical Technology Co.,ltd. | 2026 | — |
| +3 | K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026 | — |
| +1 | K070014 | Auto Detect for Telaheart DR200/E-a | North East Monitoring, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2026 | 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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 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 |
|---|---|---|---|
| * | K041901 | SD360 Digital Recorder/SD360 Holter Digital RecorderSummary page 2…YoGi6q3 Predicate Device [21 CFR 807.92(a)(3)] * NorthEast Monitoring SD360 - K041901 * Braemar ER800 - K030856 Telaheart compared to the SD360 The subject device has the same indications for use… | 2004 |
| * | K030856 | ER800 Series Ecg Event RecorderSummary page 2…YoGi6q3 Predicate Device [21 CFR 807.92(a)(3)] * NorthEast Monitoring SD360 - K041901 * Braemar ER800 - K030856 Telaheart compared to the SD360 The subject device has the same indications for use as the predicate when used in Holte… | 2003 |
What descends from it? (5)
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 14 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K142424 (North East Monitoring, Inc., 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The Telaheart Digital Recorder can be used in Holter mode and Event Recorder mode.
Hotter Mode
Detection of Arrhythmias, Efficacy of Pharmacological Treatment, and Pacemaker Evaluation.
Event Recorder
The Telaheart event recorder module is a patient activated device designed to record and for diagnostic evaluation of transient symptoms (such as dizziness, palpitations, syncope, and chest pain). Once data is recorded, the data is transmitted via telephone for evaluation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061293 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061293: Telaheart Digital Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061293
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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