510(k) Report

Devices descending from K100226

37 later devices reach Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121696Wireless ThermometerRaling Medical Company201236—
+2K132761Wireless ThermometerRaiing Medical Company201435—
+3K202603Temp PalIweecare Co., Ltd.20212—
+3K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd.201627—
+3K152975VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company20163—
+4K222588Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1Iweecare Co., Ltd.20231—
+4K181013Fever ScoutVivaLNK, Inc.201826—
+4K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company20182—
+5K250401AION TempShield™Aion Biosystems, Inc.20250—
+5K240333Wearable Digital Thermometer (T31)Guangdong Genial Technology Co., Ltd.20240—
+5K240220Aulisa Temperature Module (TM0002)Taiwan Aulisa Medical Devices Technologies, Inc.20240—
+5K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+5K203215Radius T wearable thermometerMasimo Corporation20212—
+5K202791iHealth Clinical Digital ThermometerAndon Health Co, Ltd.20211—
+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—
+6K223721Masimo StorkMasimo Corporation20230—
+6K232010iTEMPSHIELDAion Biosystems, Inc.20231—
+6K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+6K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+6K222550Current Health SystemCurrent Health, Ltd.20221—
+6K211352Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd.20210—
+6K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+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—