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 RhythMedix, LLC, iRhythm Technologies, Inc. and Smartcardia SA.
FDA 510(k) Cleared Outpatient Cardiac Telemetry Devices (Product Code QYX)
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 - 5 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QYX have taken an average of 323 days to reach a decision - up from 126 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 →