510(k) Report

Devices descending from K171816

12 later devices reach Kardia Band System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181823KardiaAIAliveCor, Inc.20196—
+1K182456Study WatchVerily Life Sciences, LLC20193—
+1K181998CardioBand ECG Event RecorderSamsung Strategy and Innovation Center (Ssic)20180—
+2K200884B-Secur HeartKey Software LibraryB-Secur, Ltd.20200—
+2K201985KardiaAIAliveCor, Inc.20200—
+2K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20202—
+2K183319Triangle SystemAliveCor, Inc.20193—
+3K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC20220—
+3K213409ZEUS System (Zio Watch)iRhythm Technologies, Inc.20220—
+3K210753KardiaMobile 6LAliveCor, Inc.20212—
+4K231424HeartBeam AIMIGo (TM) SystemHeartbeam, Inc.20240—
+4K220350KardiaMobile 6LAliveCor, Inc.20220—