# K233584: RhythmStar System

- Pathway: 510(k) (Traditional)
- Applicant: RhythMedix, LLC
- Decided: Jul 8, 2024 after 244 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: 12 generations back to K882803 (1988). 63 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141813: Rhythmstar System, RhythMedix, LLC (2014) Summary page 5.
- K163512: Zio AT ECG Monitoring System, iRhythm Technologies, Inc. (2017) Summary page 5.

## Most influential descendants
- K250793: RhythmStar System (SL) (2026), 0 descendants of its own

## Indications for use
The RhythmStar 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 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 retrospectively reviewed by a medical professional at a monitoring center. The RhythmStar system is not intended for real-time monitoring. The data received from the RhythmStar device can be used for retrospective review, arrhythmia analysis, and further evaluation, reporting and signal measurements using RhythmStar system or a compatible arrhythmia analysis software that has been FDA cleared for Lead II analysis using non-traditional wet electrode placement. The RhythmStar system is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, or provide for life support. The RhythmStar system does not provide interpretive or diagnostic statements. Interpretation and diagnosis are the responsibility of a physician. RhythmStar is for prescription use only.

Source page: https://510kreport.com/device/K233584
Methodology: https://510kreport.com/methodology