# K141813: Rhythmstar System

- Pathway: 510(k) (Traditional)
- Applicant: RhythMedix, LLC
- Decided: Aug 5, 2014 after 29 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K963725 (1997). 16 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131699: Emotion Ecg Mobile, Mega Electronics, Ltd. (2013) Summary page 4.
- K083535: Heartrak Smart Ecat, Universal Medical, Inc. (2008) Summary page 4.

## Most influential descendants
- K183704: RX-1 Rhythm Express Remote Cardiac Monitoring System (2019), 2 descendants of its own
- K233584: RhythmStar System (2024), 1 descendant of its own
- K200833: RX-1 Rhythm Express Remote Cardiac Monitoring System (2020), 1 descendant of its own
- K172311: BioFlux Device (2017), 1 descendant of its own
- 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 data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented and can be reviewed by a medical professional. The data received from the RhythmStar device can be used by another device for arrhythmia analysis, reporting and signal measurements. The RhythmStar system is not intended to sound any alarms. The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. RhythmStar is for prescription use only.

Source page: https://510kreport.com/device/K141813
Methodology: https://510kreport.com/methodology