510(k) Report

Devices descending from K160306

27 later devices reach Cloud Smart Thermometer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181013Fever ScoutVivaLNK, Inc.201826—
+2K250401AION TempShield™Aion Biosystems, Inc.20250—
+2K240220Aulisa Temperature Module (TM0002)Taiwan Aulisa Medical Devices Technologies, Inc.20240—
+2K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+2K203215Radius T wearable thermometerMasimo Corporation20212—
+2K191978Fever GardeHubdic Co., Ltd.20200—
+2K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+3K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+3K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+3K241397HinscopeHinlab Sas20240—
+3K223721Masimo StorkMasimo Corporation20230—
+3K232010iTEMPSHIELDAion Biosystems, Inc.20231—
+3K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+3K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+3K222550Current Health SystemCurrent Health, Ltd.20221—
+3K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+4K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+4K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+4K232915EpiMonitorEmpatica S.r.l.20241—
+4K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+4K231506Current Health SystemCurrent Health, Ltd.20230—
+5K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+5K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+5K252981EmbraceMiniEmpatica S.r.l.20251—
+5K250515EpiMonitorEmpatica S.r.l.20250—
+5K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+5K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—