510(k) Report

Devices descending from K854030

129 later devices reach Wrist Actigraph through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc.20250—
+7K250515EpiMonitorEmpatica S.r.l.20250—
+7K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+7K250153Neu PlatformNeuhealth Digital, Ltd.20251—
+7K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+7K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+7K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+7K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+7K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+7K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+7K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+7K183052ID-Cap SystemEtectrx, Inc.20190—
+7K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K162855Reveal LINQMedtronic, Inc.2017111
+7K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+8K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+8K241397HinscopeHinlab Sas20240—
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+8K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+8K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+8K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+9K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K230375Biomonitor IVBiotronik, Inc.20231—
+11K261074Biomonitor IV (471155)Biotronik, Inc.20260—