# K982803: Heartlink, Model II

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Telecom Corp.
- Decided: Nov 13, 1998 after 95 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: 1 generation back to K843503 (1984). 3 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934913: Heartrac Ecg Monitoring System, Cardiac Telecom Corp. (1995) Summary page 7.
- K880626: King of Hearts, Instromedix, Inc. (1988) Summary page 7.
- K843503: Aegis Ambulatory Monitoring System, Aegis Medical Systems, Inc. (1984) Summary page 7.

## Most influential descendants
- K071995: CG-6108 Continuous Ecg Monitor and Arrhythmia Detector (2007), 25 descendants of its own
- K081257: CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia Detector (2008), 18 descendants of its own
- K093288: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection (2010), 7 descendants of its own
- K090037: Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model Pocketecg (2009), 7 descendants of its own
- K100155: Truvue Wireless Ambulatory Ecg Monitoring System (2010), 6 descendants of its own

## Indications for use
1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia, 2. Specific criteria for indications for use are as follows: Patients requiring monitoring for arrhythmia-inducing co-morbid conditions such as Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias Patients requiring arrhythmia evaluation for etiology of stroke or Transient cerebral ischemia,

Source page: https://510kreport.com/device/K982803
Methodology: https://510kreport.com/methodology