Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1025](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1025) → QYX — Outpatient Cardiac Telemetry # QYX · Outpatient Cardiac Telemetry _Cardiovascular · 21 CFR 870.1025 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX ## Overview - **Product Code:** QYX - **Device Name:** Outpatient Cardiac Telemetry - **Regulation:** [21 CFR 870.1025](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1025) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs. ## Classification Rationale Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document. ## Special Controls *Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document. ## Recent Cleared Devices (20 of 20) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K241179](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K241179.md) | Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) | VivaQuant, Inc. | Jul 11, 2025 | SESE | | [K240653](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K240653.md) | SmartCardia 7L Platform (MCT) | Smartcardia SA | Oct 31, 2024 | SESE | | [K240029](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K240029.md) | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | Oct 21, 2024 | SESE | | [K233584](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K233584.md) | RhythmStar System | RhythMedix, LLC | Jul 8, 2024 | SESE | | [K162956](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K162956.md) | NOWCARDIO SYSTEM | Contex International Technologies (Canada), Inc. | Sep 22, 2017 | SESE | | [K170565](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K170565.md) | LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L | Lifewatch Services, Inc. | Aug 1, 2017 | SESE | | [K163512](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K163512.md) | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | Jun 2, 2017 | SESE | | [K160064](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K160064.md) | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | Mar 11, 2016 | SESE | | [K133753](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K133753.md) | MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR | Infobionic, Inc. | Sep 19, 2014 | SESE | | [K133701](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K133701.md) | NUVANT MCT SYSTEM | Corventis, Inc. | Feb 6, 2014 | SESE | | [K113372](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K113372.md) | NUVANT, MOBILC CARDIAC TELEMETRY | Corventis, Inc. | Mar 7, 2012 | SESE | | [K111917](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K111917.md) | NUVANT, MOBILE CARDIAC TELEMETRY | Corventis, Inc. | Aug 24, 2011 | SESE | | [K103706](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K103706.md) | THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR | Applied Cardiac Systems, Inc. | Aug 24, 2011 | SESE | | [K093288](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K093288.md) | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION | Cardionet, Inc. | Apr 8, 2010 | SESE | | [K090696](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K090696.md) | NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM | Corventis, Inc. | Jun 19, 2009 | SESE | | [K072558](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K072558.md) | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 | Cardionet, Inc. | Dec 5, 2007 | SESE | | [K063222](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K063222.md) | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 | Cardionet, Inc. | Nov 14, 2006 | SESE | | [K052240](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K052240.md) | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 | Cardionet, Inc. | Oct 19, 2005 | SESE | | [K020632](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K020632.md) | ENGUARD REMOTE PATIENT MONITOR | Mennen Medical , Ltd. | Mar 15, 2002 | SESE | | [K982803](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX/K982803.md) | HEARTLINK, MODEL II | Cardiac Telecom Corp. | Nov 13, 1998 | SESE | ## Top Applicants - Cardionet, Inc. — 4 clearances - Corventis, Inc. — 4 clearances - Infobionic, Inc. — 2 clearances - iRhythm Technologies, Inc. — 2 clearances - Applied Cardiac Systems, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/QYX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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