Product Code: QYX FDA class 2 21 CFR 870.1025

Outpatient Cardiac Telemetry

Cardiovascular

The outpatient cardiac telemetry device (product code QYX) is a Class 2 Cardiovascular prescription device (regulation 870.1025) intended to continuously record and analyze electrocardiograms in outpatient settings, with detected events transmitted to the prescribing clinician via a 24/7 attended analysis center. Requiring 510(k) clearance, it is explicitly not intended for detection or notification of hemodynamically unstable or life-threatening arrhythmias, not for patients at elevated risk of serious cardiovascular events requiring prompt intervention, and not for monitoring during cardiac rehabilitation outside healthcare facilities. It is not an implant and is not life-sustaining.

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510(k)s

FEI Numbers

Registration Numbers

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Years Active

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Basic Information

Product Code: QYX
Device Class: FDA class 2
Regulation Number: 870.1025
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 21 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250793	RhythmStar System (SL)	Apr 21, 2026	Substantially Equivalent	RhythMedix, LLC
K241179	Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)	Jul 11, 2025	Substantially Equivalent	VivaQuant, Inc.
K240653	SmartCardia 7L Platform (MCT)	Oct 31, 2024	Substantially Equivalent	Smartcardia SA
K240029	Zio AT® device (A100A1001)	Oct 21, 2024	Substantially Equivalent	iRhythm Technologies, Inc.
K233584	RhythmStar System	Jul 08, 2024	Substantially Equivalent	RhythMedix, LLC
K162956	NOWCARDIO SYSTEM	Sep 22, 2017	Substantially Equivalent	Contex International Technologies (Canada), Inc.
K170565	LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L	Aug 01, 2017	Substantially Equivalent	Lifewatch Services, Inc.
K163512	Zio AT ECG Monitoring System	Jun 02, 2017	Substantially Equivalent	iRhythm Technologies, Inc.
K160064	MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System	Mar 11, 2016	Substantially Equivalent	Infobionic, Inc.
K133753	MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR	Sep 19, 2014	Substantially Equivalent	Infobionic, Inc.
K133701	NUVANT MCT SYSTEM	Feb 06, 2014	Substantially Equivalent	Corventis, Inc.
K113372	NUVANT, MOBILC CARDIAC TELEMETRY	Mar 07, 2012	Substantially Equivalent	Corventis, Inc.
K111917	NUVANT, MOBILE CARDIAC TELEMETRY	Aug 24, 2011	Substantially Equivalent	Corventis, Inc.
K103706	THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR	Aug 24, 2011	Substantially Equivalent	Applied Cardiac Systems, Inc.
K093288	CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION	Apr 08, 2010	Substantially Equivalent	Cardionet, Inc.
K090696	NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM	Jun 19, 2009	Substantially Equivalent	Corventis, Inc.
K072558	CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005	Dec 05, 2007	Substantially Equivalent	Cardionet, Inc.
K063222	CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004	Nov 14, 2006	Substantially Equivalent	Cardionet, Inc.
K052240	CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002	Oct 19, 2005	Substantially Equivalent	Cardionet, Inc.
K020632	ENGUARD REMOTE PATIENT MONITOR	Mar 15, 2002	Substantially Equivalent	Mennen Medical , Ltd.
K982803	HEARTLINK, MODEL II	Nov 13, 1998	Substantially Equivalent	Cardiac Telecom Corp.