# K142424: DR300 Holter Monitor

- Pathway: 510(k) (Traditional)
- Applicant: North East Monitoring, Inc.
- Decided: Nov 25, 2014 after 88 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: 4 generations back to K923930 (1992). 8 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061293: Telaheart Digital Recorder, North East Monitoring, Inc. (2006) Summary page 4.

## Most influential descendants
- 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
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.

Source page: https://510kreport.com/device/K142424
Methodology: https://510kreport.com/methodology