510(k) · Cleared
ClearedSD360 Digital Recorder/SD360 Holter 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 31, 2004 as substantially equivalent to K001288 (North East Monitoring, Inc., 2000) after a 48-day review. Its family tree reaches back 1 generation to 2000. 6 later devices descend from it.
- Decided
- Aug 31, 2004
- Review
- 48 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001288 (2000). 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001288 DR180-IINorth East Monitoring, Inc. · 2000
- This deviceK041901 SD360 Digital Recorder/SD360 Holter Digital RecorderNorth East Monitoring, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK061293 Telaheart Digital RecorderNorth East Monitoring, Inc. · 2006
- Descendant · 2 generations on · 3 of its ownK142424 DR300 Holter MonitorNorth East Monitoring, Inc. · 2014
- Descendant · 3 generations on · 2 of its ownK151787 Holter SystemEdan Instruments, Inc. · 2016
- Descendant · 4 generations on · 0 of its ownK254119 Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK251591 Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K061293Telaheart Digital RecorderNorth East Monitoring, Inc. · 2006 · cites it directly5descendants
- K142424DR300 Holter MonitorNorth East Monitoring, Inc. · 2014 · 2 generations on3descendants
- K151787Holter SystemEdan Instruments, Inc. · 2016 · 3 generations on2descendants
- K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…Shenzhen Xinyan Medical Technology Co.,ltd. · 2026 · 4 generations on0descendants
- K251591Holter ECG and ABP system (HolterABP)Edan Instruments, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001288 | DR180-II | North East Monitoring, Inc. | 2000 | — |
| 0 (this device) | K041901 | SD360 Digital Recorder/SD360 Holter Digital Recorder | North East Monitoring, Inc. | 2004 | — |
| +1 | K061293 | Telaheart Digital Recorder | North East Monitoring, Inc. | 2006 | — |
| +2 | K142424 | DR300 Holter Monitor | North East Monitoring, Inc. | 2014 | — |
| +3 | K151787 | Holter System | Edan Instruments, Inc. | 2016 | — |
| +4 | K254119 | Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart… | Shenzhen Xinyan Medical Technology Co.,ltd. | 2026 | — |
| +4 | K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K001288 | DR180-IISummary page 1…ph (without analysis) Classification: Class 11, 21 CFR 870.2800, MWJ Predicate Device 121 CFR 807.92(a)(3O) · NorthEast Monitoring DR180 11 Holter Recorder - K001288 The subject device has the same indications for use as the predicate. Both the subject device and predicate device can… | 2000 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061293 | Telaheart Digital Recorder | 2006 | 5 |
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?
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?
1. Detection of Arrhythmias: The NorthEast Monitoring, Inc. SD360 Digital Recorder is indicated for use in continuous monitoring of cardiac rhythm when intermittent arrhythmia are suspected due to patient symptoms such as palpitations, transient ischemic attacks (TIAs), syncope (fainting), or other such symptoms as determined by the physician. 2. Efficacy of Treatment: The NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for use to determine…
Read the full statement (142 words)
1. Detection of Arrhythmias: The NorthEast Monitoring, Inc. SD360 Digital Recorder is indicated for use in continuous monitoring of cardiac rhythm when intermittent arrhythmia are suspected due to patient symptoms such as palpitations, transient ischemic attacks (TIAs), syncope (fainting), or other such symptoms as determined by the physician.
2. Efficacy of Treatment: The NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for use to determine whether current pharmacological treatment(s) of known arrhythmia is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment.
3. Pacemaker Evaluation: The NorthEast Monitoring Inc. SD360 Digital Recorder is indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits.
4. The NorthEast Monitoring SD360 Digital Recorder is to be used by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041901: SD360 Digital Recorder/SD360 Holter Digital Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041901
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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