510(k) Report

Devices descending from K063542

33 later devices reach Wireless Temperature Monitor / Models ST323C and ST323F. through their predicates, nearest generation first.

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