510(k) Report

Devices descending from K010462

68 later devices reach Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031503Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation200367—
+2K092958Avita Scaneo IR Thermometer, Models TS2X & TS3X SeriesAvita Corporation20090—
+2K052849Infrared Thermometer, Fdir-V1Famidoc Technology Co., Ltd.200524—
+2K050463Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110 Ear/Skin/Surface IR…Taidoc Technology Corporation200540—
+3K161933The Braun ThermoScan® 3 High Speed Compact Ear ThermometerKaz USA, Inc., A Helen of Troy Company20160—
+3K113761Infrared ThermometerFamidoc Technology Co., Ltd.20127—
+3K100488IR Ear/Forehead Thermometer Mode DX6635, DX6637, DTH1081Shenzhen Dongdixin Technology Co., Ltd.201001
+3K101736Non-Contact Forehead Infrared Thermometer, Model DT-8806H, Body Infrared Thermometer…Shenzhen Everbest Machinery Industry Co., Ltd.20103—
+3K080759Thermoflash LX-26Jxb Co. Ltd Guangzhou (China)20089—
+3K062445Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd.200739—
+4K203170Infrared Thermometer Models: DT-8806S, DT-8807SShenzhen Everbest Machinery Industry Co., Ltd.20211—
+4K171214Infrared ThermometerShenzhen Brav Electronic Technologies Co., Ltd.20186—
+4K160358DT-100Mediana Co., Ltd.20170—
+4K102947Non-Contact Infrared ThermometerK-Jump Health Co., Ltd.20118—
+4K081256Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd.200838—
+5K221800Infrared Thermometer (Model: Y20001, Y20002)Zhangzhou Easepal Medical Science and Technology Co., Ltd.20220—
+5K201600Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27…Kangfu Medical Equipment Factory20210—
+5K191283Infrared Thermometer, Breeze modelSuzhou Melodicare Medical Technology Co., Ltd.20190—
+5K181215Infrared ThermometerShenzhen Finicare Co., Ltd.20190—
+5K182133Infrared ThermometerShenzhen AOJ Medical Technology Co., Ltd.20182—
+5K172889Infrared ThermometerShenzhen Pacom Medical Instruments 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—
+6K221039Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F…Shenzhen AOJ Medical Technology Co., Ltd.20221—
+6K210118INFRARED BODY THERMOMETER (Model: YK-001)Longnan Renzhong Medical Equipment Co., Ltd.20210—
+6K202111Medical infrared forehead thermometerHunan Honggao Electronic Technolofy Co., Ltd.20210—
+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—
+7K232128Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)Shenzhen AOJ Medical Technology Co., Ltd.20230—
+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—