510(k) Report

Devices descending from K023956

34 later devices reach Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063542Wireless Temperature Monitor / Models ST323C and ST323F.Mesure Technology Co., Ltd.200733—
+2K143267TempTraq TT-100Blue Spark Technologies, Inc.201532—
+3K201977TempTraqBlue Spark Technologies, Inc.20201—
+3K162137Fever Scout™ Continuous Monitoring thermometerVivaLNK, Inc.201729—
+4K233280SteadyTempSteadysense GmbH20240—
+4K191620Vitls PlatformVitls, Inc.20202—
+4K180767FEMON Banana ThermometerLife Science Technology, Inc.20190—
+4K181013Fever ScoutVivaLNK, Inc.201826—
+5K250401AION TempShield™Aion Biosystems, Inc.20250—
+5K240220Aulisa Temperature Module (TM0002)Taiwan Aulisa Medical Devices Technologies, Inc.20240—
+5K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+5K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+5K203215Radius T wearable thermometerMasimo Corporation20212—
+5K191978Fever GardeHubdic Co., Ltd.20200—
+5K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+6K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+6K241397HinscopeHinlab Sas20240—
+6K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+6K223721Masimo StorkMasimo Corporation20230—
+6K232010iTEMPSHIELDAion Biosystems, Inc.20231—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+7K232915EpiMonitorEmpatica S.r.l.20241—
+7K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+7K231506Current Health SystemCurrent Health, Ltd.20230—
+8K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+8K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+8K252981EmbraceMiniEmpatica S.r.l.20251—
+8K250515EpiMonitorEmpatica S.r.l.20250—
+8K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+8K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—