Outpatient Cardiac Telemetry
FDA product code QYX · Class II (moderate risk) · 21 CFR 870.1025 · Cardiovascular
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.
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250793 | RhythmStar System (SL)QYX · Traditional | RhythMedix, LLC | 04/21/2026SE |
| K241179 | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)QYX · Traditional | VivaQuant, Inc. | 07/11/2025SE |
| K240653 | SmartCardia 7L Platform (MCT)QYX · Traditional | Smartcardia SA | 10/31/2024SE |
| K240029 | Zio AT® device (A100A1001)QYX · Traditional | iRhythm Technologies, Inc. | 10/21/2024SE |
| K233584 | RhythmStar SystemQYX · Traditional | RhythMedix, LLC | 07/08/2024SE |
| K162956 | Nowcardio SystemQYX · Abbreviated | Contex International Technologies (Canada), Inc. | 09/22/2017SE |
| K170565 | LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3LQYX · Traditional | Lifewatch Services, Inc. | 08/01/2017SE |
| K163512 | Zio AT ECG Monitoring SystemQYX · Traditional | iRhythm Technologies, Inc. | 06/02/2017SE |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemQYX · Abbreviated | Infobionic, Inc. | 03/11/2016SE |
| K133753 | Mome ECG Continuous Detection and Arrhythmia DetectorQYX · Traditional | Infobionic, Inc. | 09/19/2014SE |
| K133701 | Nuvant MCT SystemQYX · Special | Corventis, Inc. | 02/06/2014SE |
| K113372 | Nuvant, Mobilc Cardiac TelemetryQYX · Special | Corventis, Inc. | 03/07/2012SE |
| K111917 | Nuvant, Mobile Cardiac TelemetryQYX · Abbreviated | Corventis, Inc. | 08/24/2011SE |
| K103706 | The Core (Cardiac Outpatient Realtime ECG) MonitorQYX · Abbreviated | Applied Cardiac Systems, Inc. | 08/24/2011SE |
| K093288 | Cardionet Ambulatory ECG Monitor with Arrhythmia DetectionQYX · Abbreviated | Cardionet, Inc. | 04/08/2010SE |
| K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry SystemQYX · Special | Corventis, Inc. | 06/19/2009SE |
| K072558 | Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model CN1005QYX · Abbreviated | Cardionet, Inc. | 12/05/2007SE |
| K063222 | Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model CN1004QYX · Special | Cardionet, Inc. | 11/14/2006SE |
| K052240 | Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model 1002QYX · Abbreviated | Cardionet, Inc. | 10/19/2005SE |
| K020632 | Enguard Remote Patient MonitorQYX · Special | Mennen Medical , Ltd. | 03/15/2002SE |
| K982803 | Heartlink, Model IIQYX · Traditional | Cardiac Telecom Corp. | 11/13/1998SE |