# K012241: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001

- Pathway: 510(k) (Traditional)
- Applicant: Cardionet, Inc.
- Decided: Feb 1, 2002 after 199 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: 1 generation back to K882803 (1988). 2 ancestors in all.
76 later devices descend from it; 3 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003707: Cardionet Ambulatory Ecg Monitor, Model CN1000A, Cardionet (2001) Summary page 1.
- K882803: ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST, Advanced Cardiovascular Systems, Inc. (1988) Summary page 1.

## Most influential descendants
- K052240: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 (2005), 75 descendants of its own
- K063222: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 (2006), 73 descendants of its own
- K072558: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 (2007), 67 descendants of its own
- K083287: Avivo Mobile Patient Management System (2009), 57 descendants of its own
- K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System (2009), 40 descendants of its own

## Indications for use
Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia. Patients with dizziness or lightheadedness Patients with palpitations Patients with syncope of unknown etiology Patients who require monitoring for non life-threatening arrhythmias, such as atrial fibrillation, other supra-ventricular arrhythmias, evaluation of various bradyarrhythmias and intermittent bundle branch block. This includes post operative monitoring for these rhythms Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation 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.

Source page: https://510kreport.com/device/K012241
Methodology: https://510kreport.com/methodology