510(k) Report

Devices descending from K033790

80 later devices reach Thermofocus 0800, 0900, 01500 and 0700 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081160Avita Radar Thermo IR Thermometer, NT1 SeriesAvita Corporation200838—
+1K072108Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L.200740—
+2K134043NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc)201436—
+2K121428Non-Contact Clinical ThermometerRadiant Innovation, Inc.201220—
+2K100953Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH201018—
+2K092959Avita Radar Thermo IR Thermometer, Model NT 152Avita Corporation20090—
+3K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)Radiant Innovation, Inc.20240—
+3K191829Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH202011—
+3K191668Infrared Forehead Thermometer (Model IR-FT)Comper Chuangxiang (Beijing) Technology Co., Ltd.20191—
+3K190242Tyto ThermometerTyto Care, Ltd.20191—
+3K173048No-contact Forehead ThermometerDongguan Simzo Electronic Technology Co., Ltd.20182—
+3K163601RII Smart IR ThermometerRadiant Innovation, Inc.20180—
+3K180207Non-contact Infrared ThermometerAlicn Medical (Shenzhen), Inc.20180—
+3K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.20183—
+3K170662Non Contact Infrared Forehead ThermometerIntrinity Global Limited201710—
+3K163516Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen of Troy Company201716—
+3K162509Infrared Non-contact Thermometer, Model ACT8100Easywell Biomedicals, Inc.20170—
+3K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc.201714—
+3K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd.20160—
+3K160544Withings Thermo (Model SCT01)Withings20161—
+3K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+4K252474Withings BeamO (SCT02)Withings20250—
+4K223037Infrared Thermometer, Model: IR8807Shen Zhen Rong Feng Technology Co., Ltd.20230—
+4K223785N9+Nonagon, Ltd.20230—
+4K220657Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)Zhejiang Rongsheng Industrial Co., Ltd.20230—
+4K213038Infrared Forehead Thermometer, model: HS-9802DJiaxing Shangjia Intelligence Technology Co., Ltd.20220—
+4K211776Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)Microlife Intellectual Property GmbH20221—
+4K211752Infrared ThermometerBeijing Choice Electronic Technology Co., Ltd.20220—
+4K211744Non-Contact Infrared Thermometer, model HL710HHealth & Life Co., Ltd.20210—
+4K203497Infrared Thermometer (Model K9)Kangzhan Communication Electronics Co., Ltd.20210—
+4K202296Infrared Forehead Thermometer, Model BSX976Shenzhen Bsx Technology Electronics Co., Ltd.20210—
+4K202741Infrared Forehead ThermometerShenzhen Combei Technology Co., Ltd.20210—
+4K210014Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)Guandong Genial Technology Co., Limited20210—
+4K202483MyHomeDocMyhomedoc, Ltd.20211—
+4K201508Infrared ThermometerDongguan Prestige Sporting Goods Co., Ltd.20210—
+4K202420Infrared Forehead ThermometerConmo Electronic Company Limited20211—
+4K201536Infrared Forehead ThermometerHangzhou Qingyuan Medical Equipment Technology Co., Ltd.20210—
+4K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+4K201582Non-contact Electronic Forehead Infrared ThermometerZhongshan Jinli Electronic Weighing  Equipment Co., Ltd.20210—
+4K201579Infrared ThermometerShenzhen Xunwei Industrial Co., Ltd.20210—
+4K200159Non-contact Infrared Body Thermometer, model:HTD8823USHetaida Technology Co., Ltd.20210—
+4K200781Infrared Body ThermometerHeitaida Technology Co., Ltd.20200—
+4K201864YUWELL Infrared ThermometerJiangsu Yuyue Medical Equipment & Supply Co., Ltd.20201—
+4K193253Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd.20204—
+4K193213Vicks VNT200 No Touch Forehead ThermometerKaz USA, Inc., A Helen of Troy Company20200—
+4K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+4K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd.20198—
+4K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+4K190873Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.20192—
+4K182597Infrared thermometerShenzhen Pango Electronic Co., Ltd.20193—
+4K180355Advocate Non-Contact Infrared ThermometerBroadmaster Biotech, Corp.20193—
+4K181242Braun BNT400 No Touch + Forehead ThermometerKaz USA, Inc., A Helen of Troy Company20181—
+4K181015Braun BFH175 Infrared Forehead ThermometerKaz USA, Inc., A Helen of Troy Company20180—
+4K180385Infrared Body ThermometerHetaida Technology Co., Ltd.20180—
+5K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+5K243136Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206…Shenzhen Finicare Co., Ltd.20250—
+5K222057ThermoclickT&R BIOFAB CO., Ltd.20230—
+5K220276Infrared Thermometer TET-351Truly Instrument Limited20230—
+5K221170Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106…Shenzhen AOJ Medical Technology Co., Ltd.20220—
+5K220084Infrared Forehead ThermometerQingdao Yasee Medical Device Co., Ltd.20220—
+5K213515WesperO2Wesper, Inc.20220—
+5K212346Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618Shenzhen Pango Medical Electronics Co., Ltd.20220—
+5K213011Infrared Thermometer (model: E201)Bioland Technology, Ltd.20221—
+5K210171Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)Sichuan Youkede Medical Equipment Co.,Ltd20220—
+5K213084Ear Thermometer, Model ET005, ET008, ET009Guangzhou Berrcom Medical Device Co., Ltd.20220—
+5K213079Ear Thermometer, Model ET001Guangzhou Berrcom Medical Device Co., Ltd.20220—
+5K213082Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311Guangzhou Berrcom Medical Device Co., Ltd.20220—
+5K211629Infrared forehead thermometer LD-FT-100BHonsun (Nantong) Co., Ltd.20210—
+5K202481ThermArt (Model IR-EFT)Comper Chuangxiang (Beijing) Technology Co., Ltd.20210—
+5K202440Infrared ThermometerShenzhen Sonida Digital Technology Co., Ltd.20210—
+5K203454Infrared ThermometerShandong Zhushi Pharmaceutical Group Co., Ltd.20210—
+5K202591Body Infrared Thermometer HT-820DDongguan Xintai Instrument Co., Ltd.20210—
+5K201980Infrared ThermometerContec Medical Systems Co.,Ltd20200—
+5K200710Infrared PT2L Digital No-Touch ThermometerAndon Health Co, Ltd.20200—
+5K200531iHealth Infrared No-Touch Forehead ThermometerAndon Health Co, Ltd.20201—
+5K190984Infrared Forehead ThermometerXiamen Ants Bro Technology Co., Ltd.20200—
+5K191004Advocate Non-Contact Infrared ThermometerBroadmaster Biotech, Corp.20191—
+6K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.20250—
+6K202753iHealth Wireless No-Touch Forehead ThermometerAndon Health Co, Ltd.20210—
+6K201161Infrared Thermometer Model E127Bioland Technology, Ltd.20200—