RhythmStar System SL

• FDA 510(k) K250793 decided 21 Apr 2026 Active
• FDA GUDID UDI-DI 00868282000237 listed 29 Apr 2026 Listed

1. 21 Apr 2026 Cleared FDA 510(k) K250793
2. 29 Apr 2026 Listed FDA GUDID 00868282000237

Trade name

RhythmStar System

Generic name

Electrocardiographic ambulatory recorder

Model / reference

SL

Primary DI / UDI-DI

00868282000237

510(k) Number

K250793 ↗

FDA product code

QYX

GMDN term

Electrocardiographic ambulatory recorder

Device class

Class II

Regulation number

870.1025

GUDID distribution status

In Commercial Distribution

MRI safety

MR Unsafe

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

• Enguard Remote Patient Monitor by Mennen Medical, Inc.
• NOWCARDIO SYSTEM by Contex International Technologies (Canada), Inc.
• MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System by Infobionic, Inc.
• HEARTLINK, MODEL II by Cardiac Telecom Corp.
• 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

• 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

• Rhythmstar System

  Class II

  FDA 510(k) K141813 Active Cleared 5 Aug 2014

See all devices from RhythMedix, LLC →