# K140548: Corcam Heart Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Corcam Technologia, SA
- Decided: May 23, 2014 after 80 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CardioNet ECG Monitor with Arrhythmia Detection: named in the summary without a submission number
- (no number) Body Guardian: named in the summary without a submission number
- (no number) CORE™ ECG Monitor: named in the summary without a submission number

## Indications for use
The Corcam Heart Monitor is a portable device intended to continuously monitor a patient's cardiac condition for early signs of arrhythmia. 1. Adult patients who have demonstrated a need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease. 2. Adult patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: dizziness or lightheadedness; syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and dyspnea (shortness of breath). 3. Adult patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. 4. Adult patients who require outpatient monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).

Source page: https://510kreport.com/device/K140548
Methodology: https://510kreport.com/methodology