FDA Product Code QYX: Outpatient Cardiac Telemetry
Devices Are Intended To Continuously Record And Analyze Electrocardiograms For Automatic Detection And Recording Of Cardiac Electrical Activity In An Outpatient Setting. Detected, Notifiable Events Are Transmitted To The Prescribing Clinician During The Monitoring Period By A 24/7 Attended Analysis Center After Review By A Qualified Individual. Devices May Allow Remote Access And Display Of Electrocardiograms Acquired. Not For Use For Detection Or Notification Of Hemodynamically Unstable Or Life-threatening Arrhythmias Or Cardiac Events Requiring Urgent Medical Response. Not Intended For Patients At Elevated Risk Of Serious Cardiovascular Events That Would Require Prompt Intervention. It Is Not Intended For Monitoring Patients During Cardiac Rehabilitation Outside Of Healthcare Facilities. Devices Are Intended For Prescription Use Only.
Leading manufacturers include Cardionet, Inc., Corventis, Inc. and Infobionic, Inc..
21
Total
21
Cleared
173d
Avg days
1998
Since
Growing category -
4 submissions in the last 2 years
vs 1 in the prior period
Review times increasing: avg
343d
recently vs 133d historically
FDA 510(k) Cleared Outpatient Cardiac Telemetry Devices (Product Code QYX)
21 devices
Cleared
Apr 21, 2026
RhythmStar System (SL)
RhythMedix, LLC
Cardiovascular
403d
Cleared
Jul 11, 2025
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)
Vivaquant, Inc.
Cardiovascular
438d
Cleared
Oct 31, 2024
SmartCardia 7L Platform (MCT)
Smartcardia SA
Cardiovascular
238d
Cleared
Oct 21, 2024
Zio AT® device (A100A1001)
iRhythm Technologies, Inc.
Cardiovascular
291d
Cleared
Jul 08, 2024
RhythmStar System
RhythMedix, LLC
Cardiovascular
244d
Cleared
Sep 22, 2017
NOWCARDIO SYSTEM
Contex International Technologies (Canada), Inc.
Cardiovascular
333d
Cleared
Aug 01, 2017
LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
Lifewatch Services, Inc.
Cardiovascular
155d
Cleared
Jun 02, 2017
Zio AT ECG Monitoring System
iRhythm Technologies, Inc.
Cardiovascular
169d
Cleared
Mar 11, 2016
MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
Infobionic, Inc.
Cardiovascular
58d
Cleared
Sep 19, 2014
MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR
Infobionic, Inc.
Cardiovascular
284d
Cleared
Feb 06, 2014
NUVANT MCT SYSTEM
Corventis, Inc.
Cardiovascular
65d
Cleared
Mar 07, 2012
NUVANT, MOBILC CARDIAC TELEMETRY
Corventis, Inc.
Cardiovascular
112d
Cleared
Aug 24, 2011
THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR
Applied Cardiac Systems, Inc.
Cardiovascular
247d
Cleared
Aug 24, 2011
NUVANT, MOBILE CARDIAC TELEMETRY
Corventis, Inc.
Cardiovascular
49d
Cleared
Apr 08, 2010
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
Cardionet, Inc.
Cardiovascular
170d
Cleared
Jun 19, 2009
NUVANT CARDIAC EVENT MONITORING SYSTEM
Corventis, Inc.
Cardiovascular
95d
Cleared
Dec 05, 2007
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005
Cardionet, Inc.
Cardiovascular
85d
Cleared
Nov 14, 2006
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004
Cardionet, Inc.
Cardiovascular
21d
Cleared
Oct 19, 2005
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002
Cardionet, Inc.
Cardiovascular
63d
Cleared
Mar 15, 2002
ENGUARD REMOTE PATIENT MONITOR
Mennen Medical , Ltd.
Cardiovascular
16d
Cleared
Nov 13, 1998
HEARTLINK, MODEL II
Cardiac Telecom Corp.
Cardiovascular
95d
About Product Code QYX - Regulatory Context
510(k) Submission Activity
21 total 510(k) submissions under product code QYX since 1998, with 21 receiving FDA clearance (average review time: 173 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QYX Product Code
Recent submissions under QYX have taken an average of 343 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.
QYX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →