510(k) Report

Devices descending from K011291

200 later devices reach Temporalscanner Thermometer, Sensortouch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203497Infrared Thermometer (Model K9)Kangzhan Communication Electronics Co., Ltd.20210—
+5K202296Infrared Forehead Thermometer, Model BSX976Shenzhen Bsx Technology Electronics Co., Ltd.20210—
+5K202741Infrared Forehead ThermometerShenzhen Combei Technology Co., Ltd.20210—
+5K210014Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)Guandong Genial Technology Co., Limited20210—
+5K202483MyHomeDocMyhomedoc, Ltd.20211—
+5K201508Infrared ThermometerDongguan Prestige Sporting Goods Co., Ltd.20210—
+5K202420Infrared Forehead ThermometerConmo Electronic Company Limited20211—
+5K201536Infrared Forehead ThermometerHangzhou Qingyuan Medical Equipment Technology Co., Ltd.20210—
+5K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+5K201582Non-contact Electronic Forehead Infrared ThermometerZhongshan Jinli Electronic Weighing  Equipment Co., Ltd.20210—
+5K201579Infrared ThermometerShenzhen Xunwei Industrial Co., Ltd.20210—
+5K201864YUWELL Infrared ThermometerJiangsu Yuyue Medical Equipment & Supply Co., Ltd.20201—
+5K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd.20204—
+5K193213Vicks VNT200 No Touch Forehead ThermometerKaz USA, Inc., A Helen of Troy Company20200—
+5K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+5K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd.20198—
+5K191283Infrared Thermometer, Breeze modelSuzhou Melodicare Medical Technology Co., Ltd.20190—
+5K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+5K190873Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.20192—
+5K182597Infrared thermometerShenzhen Pango Electronic Co., Ltd.20193—
+5K180355Advocate Non-Contact Infrared ThermometerBroadmaster Biotech, Corp.20193—
+5K181215Infrared ThermometerShenzhen Finicare Co., Ltd.20190—
+5K182133Infrared ThermometerShenzhen AOJ Medical Technology Co., Ltd.20182—
+5K181242Braun BNT400 No Touch + Forehead ThermometerKaz USA, Inc., A Helen of Troy Company20181—
+5K181015Braun BFH175 Infrared Forehead ThermometerKaz USA, Inc., A Helen of Troy Company20180—
+5K172889Infrared ThermometerShenzhen Pacom Medical Instruments Co., Ltd.20180—
+5K180385Infrared Body ThermometerHetaida Technology Co., Ltd.20180—
+5K131243Non-Contact Infrared ThermometerShenzhen Jumper Medical Equipment Co., Ltd.20135—
+5K120711Non-Contact ThermometerK-Jump Health Co., Ltd.20120—
+5K100226Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H)Rio Flexon Technology Co., Ltd.201037—
+6K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+6K243136Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206…Shenzhen Finicare Co., Ltd.20250—
+6K222057ThermoclickT&R BIOFAB CO., Ltd.20230—
+6K220276Infrared Thermometer TET-351Truly Instrument Limited20230—
+6K221039Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F…Shenzhen AOJ Medical Technology Co., Ltd.20221—
+6K221170Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106…Shenzhen AOJ Medical Technology Co., Ltd.20220—
+6K220084Infrared Forehead ThermometerQingdao Yasee Medical Device Co., Ltd.20220—
+6K213515WesperO2Wesper, Inc.20220—
+6K212346Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618Shenzhen Pango Medical Electronics Co., Ltd.20220—
+6K213011Infrared Thermometer (model: E201)Bioland Technology, Ltd.20221—
+6K210171Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)Sichuan Youkede Medical Equipment Co.,Ltd20220—
+6K213084Ear Thermometer, Model ET005, ET008, ET009Guangzhou Berrcom Medical Device Co., Ltd.20220—
+6K213079Ear Thermometer, Model ET001Guangzhou Berrcom Medical Device Co., Ltd.20220—
+6K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311Guangzhou Berrcom Medical Device Co., Ltd.20220—
+6K211629Infrared forehead thermometer LD-FT-100BHonsun (Nantong) Co., Ltd.20210—
+6K202481ThermArt (Model IR-EFT)Comper Chuangxiang (Beijing) Technology Co., Ltd.20210—
+6K210118INFRARED BODY THERMOMETER (Model: YK-001)Longnan Renzhong Medical Equipment Co., Ltd.20210—
+6K202440Infrared ThermometerShenzhen Sonida Digital Technology Co., Ltd.20210—
+6K203454Infrared ThermometerShandong Zhushi Pharmaceutical Group Co., Ltd.20210—
+6K202591Body Infrared Thermometer HT-820DDongguan Xintai Instrument Co., Ltd.20210—
+6K202111Medical infrared forehead thermometerHunan Honggao Electronic Technolofy Co., Ltd.20210—
+6K201980Infrared ThermometerContec Medical Systems Co.,Ltd20200—
+6K200710Infrared PT2L Digital No-Touch ThermometerAndon Health Co, Ltd.20200—
+6K200531iHealth Infrared No-Touch Forehead ThermometerAndon Health Co, Ltd.20201—
+6K190984Infrared Forehead ThermometerXiamen Ants Bro Technology Co., Ltd.20200—
+6K191004Advocate Non-Contact Infrared ThermometerBroadmaster Biotech, Corp.20191—
+6K160816Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)Nexmed Technology Co., Ltd.20161—
+6K161325CliniCloud Non-contact Thermometer, Model SPL1024Stethocloud Pty.Ltd (Clinicloud)20160—
+6K121696Wireless ThermometerRaling Medical Company201236—
+7K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.20250—
+7K232128Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)Shenzhen AOJ Medical Technology Co., Ltd.20230—
+7K202753iHealth Wireless No-Touch Forehead ThermometerAndon Health Co, Ltd.20210—
+7K201161Infrared Thermometer Model E127Bioland Technology, Ltd.20200—
+7K153600Consult Station TSH4D Sas20170—
+7K132761Wireless ThermometerRaiing Medical Company201435—
+8K202603Temp PalIweecare Co., Ltd.20212—
+8K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd.201627—
+8K152975VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company20163—
+9K222588Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1Iweecare Co., Ltd.20231—
+9K181013Fever ScoutVivaLNK, Inc.201826—
+9K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company20182—
+10K250401AION TempShield™Aion Biosystems, Inc.20250—
+10K240333Wearable Digital Thermometer (T31)Guangdong Genial Technology Co., Ltd.20240—
+10K240220Aulisa Temperature Module (TM0002)Taiwan Aulisa Medical Devices Technologies, Inc.20240—
+10K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.20223—
+10K203215Radius T wearable thermometerMasimo Corporation20212—
+10K202791iHealth Clinical Digital ThermometerAndon Health Co, Ltd.20211—
+10K191978Fever GardeHubdic Co., Ltd.20200—
+10K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+11K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+11K233956Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)Taiwan Aulisa Medical Devices Technologies, Inc.20250—
+11K241397HinscopeHinlab Sas20240—
+11K223721Masimo StorkMasimo Corporation20230—
+11K232010iTEMPSHIELDAion Biosystems, Inc.20231—
+11K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+11K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+11K222550Current Health SystemCurrent Health, Ltd.20221—
+11K211352Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd.20210—
+11K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+12K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+12K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+12K232915EpiMonitorEmpatica S.r.l.20241—
+12K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+12K231506Current Health SystemCurrent Health, Ltd.20230—
+13K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+13K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+13K252981EmbraceMiniEmpatica S.r.l.20251—
+13K250515EpiMonitorEmpatica S.r.l.20250—
+13K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+13K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—