# K142352: CardiacLinx

- Pathway: 510(k) (Traditional)
- Applicant: Ross Medical Technology, Inc.
- Decided: Mar 12, 2015 after 202 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 K963725 (1997). 59 ancestors in all.
No later device cites it as a predicate yet.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103706: The Core (Cardiac Outpatient Realtime Ecg) Monitor, Applied Cardiac Systems, Inc. (2011) Summary page 5.
- K100813: QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb, Pulse Biomedical, Inc. (2010) Summary page 5.
- K042799: QRS-Card Cardiology Suite, Pulse Biomedical, Inc. (2004) Summary page 5.
- K060167: Atria 3100, Atria 6100, Cardiac Science Corporation (2006) Summary page 5.

## Indications for use
MCT Mode: For 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 notification when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia, or Tachycardia occurs. Holter Mode: For use on adult patients experiencing palpitations, syncope, pre-syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG. Multi-Lead (Resting EKG) Mode: For 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. The intended use locations for CardiacLinx are in a physician's office, hospital or rehabilitation facilities, patient’s home, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional. For general hospital or clinical use by medical professionals whenever an assessment of a patient’s ambulatory ECG data is required. Allows for a trained physician or health care professional to download and analyze the data for review and to produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patient response after resuming occupational or recreational activities (e.g., after myocardial infarction or cardiac surgery), and/or evaluation of patients with pacemakers. CardiacLinx is only available for use upon the order of a physician or other related licensed medical professional. For use under the supervision of a qualified physician trained in ECG interpretation to record the electrical activity of the heart for the purpose of correlating resultant waveforms with the health of the heart muscle tissue structures.

Source page: https://510kreport.com/device/K142352
Methodology: https://510kreport.com/methodology