# K250793: RhythmStar System (SL)

- Pathway: 510(k) (Traditional)
- Applicant: RhythMedix, LLC
- Decided: Apr 21, 2026 after 403 days
- Product code: QYX (Outpatient Cardiac Telemetry)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K882803 (1988). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233584: RhythmStar System, RhythMedix, LLC (2024) Summary page 5.

## Indications for use
The RhythmStar SL System is intended for use by patients who either have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers all recorded cardiac activity to the cloud server where it is presented and can be reviewed by a medical professional at a monitoring center. The RhythmStar SL is not intended for real-time monitoring. The data received from the RhythmStar SL can be used for retrospective review, arrhythmia analysis, and further evaluation, reporting and signal measurements using RhythmStar system. The RhythmStar SL is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, or provide for life support. The RhythmStar SL does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the responsibility of a physician. RhythmStar SL is for prescription use only.

Source page: https://510kreport.com/device/K250793
Methodology: https://510kreport.com/methodology