510(k) Report

Devices descending from K131509

18 later devices reach Zoe Fluid Status Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150095ReDs Wearable SystemSensible Medical Innovations, Ltd.20151—
+1K133301Zoe Fluid Status MonitorNoninvasive Medical Technologies, Inc.201417—
+2K250922Edema Guard Monitor (EGM) CardioSet-001Cardioset Medical, Ltd.20250—
+2K211585Bodyport Cardiac ScaleBodyport, Inc.20220—
+2K180479ReDS SystemSensible Medical Innovations, Ltd.20190—
+2K172510µCor Heart Failure and Arrhythmia Management SystemZoll Manufacturing Corporation20181—
+2K142503Imed-Z Fluid Status MonitorIntersection Medical, Inc.201510—
+3K250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLC20250—
+3K243727Re:BalansMode Sensors AS20250—
+3K190939ZOLL Arrhythmia Management SysyemZoll Manufacturing Corporation20190—
+3K172507SOZOImpediMed Limited20177—
+4K193410SOZO Body Fluid AnalyzerImpediMed Limited20204—
+4K190529SOZOImpediMed Limited20191—
+5K230531SOZO ProImpediMed Limited20230—
+5K203473SOZOImpediMed Limited20213—
+6K232089SOZO ProImpediMed Limited20232—
+7K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed Limited20260—
+7K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed Limited20260—