510(k) Report

Devices descending from K141813

8 later devices reach Rhythmstar System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233584RhythmStar SystemRhythMedix, LLC20241—
+1K183704RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20192—
+1K172311BioFlux DeviceBiotricity, Inc.20171—
+1K172801ECG SENTINEL SystemCardiomedix, Inc.20170—
+2K250793RhythmStar System (SL)RhythMedix, LLC20260—
+2K233864ASSURE Wearable ECGKestra Medical Technologies, Inc.20240—
+2K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.20201—
+3K241179Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)VivaQuant, Inc.20250—