RhythmStar System (SL)
510(k) K250793
RhythmStar System (SL) is a medical device (FDA Class II; FDA product code QYX, Outpatient Cardiac Telemetry) made by RhythMedix, LLC, cleared under FDA 510(k) K250793 on 21 Apr 2026, 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 | NumberK250793 | Date21 Apr 2026 | StatusActive |
Official records
- FDA 510(k) database K250793
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QYX
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K250793
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.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| RhythmStar System SL | SL | 00868282000237 | — | On the market |
Similar devices
Other devices filed under FDA product code QYX (Outpatient Cardiac Telemetry).
- 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.
- SmartCardia 7L Platform (MCT) by SmartCardia SA