# K103706: The Core (Cardiac Outpatient Realtime Ecg) Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Applied Cardiac Systems, Inc.
- Decided: Aug 24, 2011 after 247 days
- Product code: QYX (Outpatient Cardiac Telemetry)
- 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: 5 generations back to K963725 (1997). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071995: CG-6108 Continuous Ecg Monitor and Arrhythmia Detector, Card Guard Scientific Survival, Ltd. (2007) Summary page 5.
- K020825: King of Hearts Express + AF Monitor, Card Guard Scientific Survival, Ltd. (2002) Summary page 5.
- K062282: Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0, Monebo Technologies, Inc. (2007) Summary page 5.
- K860249: The Holter Reporter (TM), Applied Cardiac Systems (1986) Summary page 5.
- K102723: Model 950-12L Holter Recorder Without Analysis, Memtec Corp. (2010) Summary page 6.
- K870880: EK10 Electrocardiograph, Burdick Corp. (1987) Summary page 6.

## Most influential descendants
- K142352: CardiacLinx (2015), 0 descendants of its own

## Indications for use
1. MCT Mode: Use on adult patients who experience transient or non-transient symptoms that may suggest cardiac arrhythmias. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia, or Tachycardia occurs. 2. Holter Mode: Use on adult patients experiencing palpitations, syncope, pre-Syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG. 3. Multi-Lead (Resting EKG) Mode: Use on adult patients for acquiring, storing and viewing/printing of up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the patient's body. Contra-indications for use: 1. Patients with potentially life-threatening arrhythmias who require inpatient monitoring; and patients who the attending physician thinks should be hospitalized. The device continuously monitors patient's ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The software does not perform diagnosis. The ECG data is provided to the medical practitioner for evaluation and diagnosis.

Source page: https://510kreport.com/device/K103706
Methodology: https://510kreport.com/methodology