510(k) · Cleared
ClearedDR300 Holter Monitor
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 Nov 25, 2014 as substantially equivalent to K061293 (North East Monitoring, Inc., 2006) after an 88-day review. Its family tree reaches back 4 generations to 1992. 3 later devices descend from it.
- Decided
- Nov 25, 2014
- Review
- 88 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K923930 (1992). 8 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK923930 Electrocardiograph TransmitterTz Medical, Inc. · 1992
- 3 generations backK981394 Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720Braemar Corp. · 1998
- 2 generations backK030856 ER800 Series Ecg Event RecorderBraemar Corp. · 2003
- 1 generation backK061293 Telaheart Digital RecorderNorth East Monitoring, Inc. · 2006
- This deviceK142424 DR300 Holter MonitorNorth East Monitoring, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK151787 Holter SystemEdan Instruments, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK254119 Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See all- K151787Holter SystemEdan Instruments, Inc. · 2016 · cites it directly2descendants
- K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026 · 2 generations on0descendants
- K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923930 | Electrocardiograph Transmitter | Tz Medical, Inc. | 1992 | — |
| −3 | K981394 | Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720 | Braemar Corp. | 1998 | — |
| −2 | K030856 | ER800 Series Ecg Event Recorder | Braemar Corp. | 2003 | — |
| −1 | K061293 | Telaheart Digital Recorder | North East Monitoring, Inc. | 2006 | — |
| 0 (this device) | K142424 | DR300 Holter Monitor | North East Monitoring, Inc. | 2014 | — |
| +1 | K151787 | Holter System | Edan Instruments, Inc. | 2016 | — |
| +2 | K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart… | Shenzhen Xinyan Medical Technology Co.,ltd. | 2026 | — |
| +2 | K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K061293 | Telaheart Digital RecorderSummary page 4…Classification: Class 2, 21 CFR 870.2800 Classification Name: Ambulatory ECG recorder Product Code: MWJ 3. PREDICATE DEVICES K061293 Telaheart Digital Recorder / DR200 4. DEVICE DESCRIPTION The DR300 is an ambulatory monitor, sometimes called a Holt… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151787 | Holter System | 2016 | 2 |
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 22 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K151787 (Edan Instruments, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K061293.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
Holter Mode: Detection of Arrhythmias, Efficacy of Pharmacological
Treatment and Pacemaker Evaluation.
Event Recorder: The 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 for evaluation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142424 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142424: DR300 Holter Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142424
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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