RhythmStar RS-10003
RhythmStar RS-10003 is an electrocardiographic ambulatory recorder (FDA Class II; FDA product code QYX, Outpatient Cardiac Telemetry) made by RhythMedix, LLC, cleared under FDA 510(k) K233584 on 8 Jul 2024 (1 earlier submission) and listed in FDA GUDID since 8 Sep 2020 (UDI-DI 00868282000220), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK233584 | Date8 Jul 2024 | StatusActive |
| United States | GUDID listing | Number00868282000220 | Date8 Sep 2020 | StatusListed |
Official records
- AccessGUDID record 00868282000220
- FDA 510(k) database K233584
- FDA 510(k) database K141813
Across registries
- FDA 510(k) K233584 decided 8 Jul 2024 Active
- FDA GUDID UDI-DI 00868282000220 listed 8 Sep 2020 Listed
Timeline
- Cleared FDA 510(k) K141813
- Listed FDA GUDID 00868282000220
- Cleared FDA 510(k) K233584
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RhythmStar
- Generic name
- Electrocardiographic ambulatory recorder
- Model / reference
- RS-10003
- Primary DI / UDI-DI
- 00868282000220
- FDA product code
- QYX
- GMDN term
- Electrocardiographic ambulatory recorder
- Device class
- Class II
- Regulation number
- 870.1025
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code QYX (Outpatient Cardiac Telemetry).
- Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) by VivaQuant, Inc
- CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 by CARDIONET, LLC
- NUVANT, MOBILE CARDIAC TELEMETRY by Corventis, Inc.
- LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L by Lifewatch Services, Inc.
- NUVANT MCT SYSTEM by Corventis, Inc.
- CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 by CARDIONET, LLC
- SmartCardia 7L Platform (MCT) by SmartCardia SA
- 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.