# K041901: SD360 Digital Recorder/SD360 Holter Digital Recorder

- Pathway: 510(k) (Abbreviated)
- Applicant: North East Monitoring, Inc.
- Decided: Aug 31, 2004 after 48 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001288 (2000). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001288: DR180-II, North East Monitoring, Inc. (2000) Summary page 1.

## Most influential descendants
- K061293: Telaheart Digital Recorder (2006), 5 descendants of its own
- K142424: DR300 Holter Monitor (2014), 3 descendants of its own
- K151787: Holter System (2016), 2 descendants of its own
- K254119: Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) (2026), 0 descendants of its own
- K251591: Holter ECG and ABP system (HolterABP) (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K041901
Methodology: https://510kreport.com/methodology