510(k) Report

Devices descending from K020825

120 later devices reach King of Hearts Express + AF Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180895AlleyeOculocare Medical AG20181—
+5K161431SimplECGNanowear, Inc.20165—
+5K152770ProBP 2400 Digital Blood Pressure DeviceMicrolife Intellectual Property GmbH201531
+6K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+6K231424HeartBeam AIMIGo (TM) SystemHeartbeam, Inc.20240—
+6K233521QT Ecg (QTERD100)QT Medical, Inc.20230—
+6K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC20220—
+6K220350KardiaMobile 6LAliveCor, Inc.20220—
+6K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+6K200884B-Secur HeartKey Software LibraryB-Secur, Ltd.20200—
+6K201985KardiaAIAliveCor, Inc.20200—
+6K201669SimpleSENSENanowear, Inc.20203—
+6K200297Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20202—
+7K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+7K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+7K212160SimpleSENSE PlatformNanowear, Inc.20211—
+7K202729Microlife Upper Arm Automatic Digital Blood Pressure MonitorMicrolife Intellectual Property GmbH20210—
+8K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+8K230375Biomonitor IVBiotronik, Inc.20231—
+9K261074Biomonitor IV (471155)Biotronik, Inc.20260—