RhythmStar System

510(k) Number

K233584 ↗

FDA product code

QYX

Device class

Class II

Regulation

21 CFR Part 870.1025

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code QYX (Outpatient Cardiac Telemetry).

• Zio AT® device (A100A1001) by IRHYTHM TECHNOLOGIES, INC.
• NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM by Corventis, Inc.
• MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR by Infobionic, Inc.
• Zio AT ECG Monitoring System by IRHYTHM TECHNOLOGIES, INC.
• THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR by Applied Cardiac Systems, Inc.
• CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 by CARDIONET, LLC
• NUVANT, MOBILC CARDIAC TELEMETRY by Corventis, Inc.
• Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) by VivaQuant, Inc
• CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 by CARDIONET, LLC
• LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L by Lifewatch Services, Inc.

• RhythmStar System SL

  Class II

  FDA 510(k) K250793 Active Cleared 21 Apr 2026 GUDID on market

• RhythmStar RS-10002V

  Class II

  FDA 510(k) K141813 Active Cleared 5 Aug 2014 GUDID on market

• RhythmStar RS-10003

  Class II

  FDA 510(k) ×2 Active Cleared 5 Aug 2014 GUDID on market

• RhythmStar System (SL)

  Class II

  FDA 510(k) K250793 Active Cleared 21 Apr 2026

See all devices from RhythMedix, LLC →