# K124060: Medical Gorithmics Unified Arrhythmia Diagnostic System

- Pathway: 510(k) (Abbreviated)
- Applicant: Medicalgorithmics S.A.
- Decided: Feb 21, 2013 after 52 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K882803 (1988). 13 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072558: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005, Cardionet, Inc. (2007) Summary page 1.
- K071130: Heartrak AF, Universal Medical, Inc. (2008) Summary page 1.
- K050731: Seer Light Extend Compact Digital Holter System, Ge Medical Systems Information Technologies (2005) Summary page 1.
- K112921: Medicalgorithmics Unified Arrhythmia Diagnostic System, Medicalgorithmics S.A. (2012)

## Most influential descendants
- K152550: Medicalgorithmics Unified Arrhythmia Diagnosic System (2015), 3 descendants of its own
- K200833: RX-1 Rhythm Express Remote Cardiac Monitoring System (2020), 1 descendant of its own
- K241179: Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) (2025), 0 descendants of its own
- K193104: Unified Arrhythmia Diagnostic System PocketECG IV (2020), 0 descendants of its own
- K173969: Medicalgorithmics Unified Cardiac Rehabilitation System (2018), 0 descendants of its own

## Indications for use
The indications for use for the PocketECG v3 monitor are as follows: 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease 2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmtas are suspected or need to be excluded; and c) dyspnea(shortness of breath) 3. Patients with palpitations with or without known arrhythrnias to obtain correlation of rhythm with symptoms. 4. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation) 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias 7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemnia, possibly secondary to atriat fibrillation or atrial flutter. 8. Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to Sound any alarms for QT interval changes. Contradictions: 1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring 2. Patients who the attending physician thinks should be hospitalized.

Source page: https://510kreport.com/device/K124060
Methodology: https://510kreport.com/methodology