510(k) Report

Devices descending from K081256

38 later devices reach Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100226Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H)Rio Flexon Technology Co., Ltd.201037—
+2K121696Wireless ThermometerRaling Medical Company201236—
+3K132761Wireless ThermometerRaiing Medical Company201435—
+4K202603Temp PalIweecare Co., Ltd.20212—
+4K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd.201627—
+4K152975VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company20163—
+5K222588Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1Iweecare Co., Ltd.20231—
+5K181013Fever ScoutVivaLNK, Inc.201826—
+5K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company20182—
+6K250401AION TempShield™Aion Biosystems, Inc.20250—
+6K240333Wearable Digital Thermometer (T31)Guangdong Genial Technology Co., Ltd.20240—
+6K240220Aulisa Temperature Module (TM0002)Taiwan Aulisa Medical Devices Technologies, Inc.20240—
+6K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+6K203215Radius T wearable thermometerMasimo Corporation20212—
+6K202791iHealth Clinical Digital ThermometerAndon Health Co, Ltd.20211—
+6K191978Fever GardeHubdic Co., Ltd.20200—
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+7K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+7K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+7K241397HinscopeHinlab Sas20240—
+7K223721Masimo StorkMasimo Corporation20230—
+7K232010iTEMPSHIELDAion Biosystems, Inc.20231—
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K211352Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd.20210—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K232915EpiMonitorEmpatica S.r.l.20241—
+8K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+9K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K252981EmbraceMiniEmpatica S.r.l.20251—
+9K250515EpiMonitorEmpatica S.r.l.20250—
+9K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+9K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—