# K151787: Holter System

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jan 27, 2016 after 210 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K963725 (1997). 60 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043010: Holter Recorder H3+, Mortara Instrument, Inc. (2005) Summary page 4.
- K050896: H12+ Holter Recorder, Mortara Instrument, Inc. (2005) Summary page 4.
- K132437: Mars Holter Analysis Workstation, Ge Medical Systems Information Technologies, Inc. (2013) Summary page 4.
- K142424: DR300 Holter Monitor, North East Monitoring, Inc. (2014) Summary page 4.
- K093288: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Cardionet, Inc. (2010) Summary page 4.

## Most influential descendants
- 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
The SE-2003/SE-2012 Holter System (including recorder and analysis software) is intended to record, analyze, display, edit and generate report of ambulatory ECG. The Holter System is intended to be used by trained personnel under the direction of doctors. The analysis results are offered to doctors on an advisory basis only. The Holter System is intended for adult, pediatric patients including infants weighing less than 10 kg. It can be used for the following indications: 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of patients for ST segment changes. 3. Evaluation of drug response in patients taking anti-arrhythmic medications. 4. Evaluation of patients with pacemakers.

Source page: https://510kreport.com/device/K151787
Methodology: https://510kreport.com/methodology