510(k) Report

Devices descending from K062445

39 later devices reach Monitoring Ear Thermometer, Model BTM-D1A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081256Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd.200838—
+2K100226Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H)Rio Flexon Technology Co., Ltd.201037—
+3K121696Wireless ThermometerRaling Medical Company201236—
+4K132761Wireless ThermometerRaiing Medical Company201435—
+5K202603Temp PalIweecare Co., Ltd.20212—
+5K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd.201627—
+5K152975VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company20163—
+6K222588Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1Iweecare Co., Ltd.20231—
+6K181013Fever ScoutVivaLNK, Inc.201826—
+6K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company20182—
+7K250401AION TempShield™Aion Biosystems, Inc.20250—
+7K240333Wearable Digital Thermometer (T31)Guangdong Genial Technology Co., Ltd.20240—
+7K240220Aulisa Temperature Module (TM0002)Taiwan Aulisa Medical Devices Technologies, Inc.20240—
+7K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+7K203215Radius T wearable thermometerMasimo Corporation20212—
+7K202791iHealth Clinical Digital ThermometerAndon Health Co, Ltd.20211—
+7K191978Fever GardeHubdic Co., Ltd.20200—
+7K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+8K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+8K241397HinscopeHinlab Sas20240—
+8K223721Masimo StorkMasimo Corporation20230—
+8K232010iTEMPSHIELDAion Biosystems, Inc.20231—
+8K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+8K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+8K222550Current Health SystemCurrent Health, Ltd.20221—
+8K211352Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd.20210—
+8K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+9K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+9K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+9K232915EpiMonitorEmpatica S.r.l.20241—
+9K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+9K231506Current Health SystemCurrent Health, Ltd.20230—
+10K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+10K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+10K252981EmbraceMiniEmpatica S.r.l.20251—
+10K250515EpiMonitorEmpatica S.r.l.20250—
+10K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+10K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—