510(k) Report

Devices descending from K072108

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121428Non-Contact Clinical ThermometerRadiant Innovation, Inc.201220—
+1K100953Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH201018—
+2K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)Radiant Innovation, Inc.20240—
+2K191829Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH202011—
+2K173048No-contact Forehead ThermometerDongguan Simzo Electronic Technology Co., Ltd.20182—
+2K163601RII Smart IR ThermometerRadiant Innovation, Inc.20180—
+2K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.20183—
+2K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc.201714—
+2K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+3K223037Infrared Thermometer, Model: IR8807Shen Zhen Rong Feng Technology Co., Ltd.20230—
+3K213038Infrared Forehead Thermometer, model: HS-9802DJiaxing Shangjia Intelligence Technology Co., Ltd.20220—
+3K211776Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)Microlife Intellectual Property GmbH20221—
+3K211752Infrared ThermometerBeijing Choice Electronic Technology Co., Ltd.20220—
+3K211744Non-Contact Infrared Thermometer, model HL710HHealth & Life Co., Ltd.20210—
+3K202741Infrared Forehead ThermometerShenzhen Combei Technology Co., Ltd.20210—
+3K210014Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)Guandong Genial Technology Co., Limited20210—
+3K202420Infrared Forehead ThermometerConmo Electronic Company Limited20211—
+3K201536Infrared Forehead ThermometerHangzhou Qingyuan Medical Equipment Technology Co., Ltd.20210—
+3K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health)20210—
+3K201582Non-contact Electronic Forehead Infrared ThermometerZhongshan Jinli Electronic Weighing  Equipment Co., Ltd.20210—
+3K201579Infrared ThermometerShenzhen Xunwei Industrial Co., Ltd.20210—
+3K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+3K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd.20198—
+3K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+3K190873Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.20192—
+3K180385Infrared Body ThermometerHetaida Technology Co., Ltd.20180—
+4K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+4K222057ThermoclickT&R BIOFAB CO., Ltd.20230—
+4K220276Infrared Thermometer TET-351Truly Instrument Limited20230—
+4K213515WesperO2Wesper, Inc.20220—
+4K213011Infrared Thermometer (model: E201)Bioland Technology, Ltd.20221—
+4K210171Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)Sichuan Youkede Medical Equipment Co.,Ltd20220—
+4K213084Ear Thermometer, Model ET005, ET008, ET009Guangzhou Berrcom Medical Device Co., Ltd.20220—
+4K213079Ear Thermometer, Model ET001Guangzhou Berrcom Medical Device Co., Ltd.20220—
+4K202481ThermArt (Model IR-EFT)Comper Chuangxiang (Beijing) Technology Co., Ltd.20210—
+4K202440Infrared ThermometerShenzhen Sonida Digital Technology Co., Ltd.20210—
+4K200710Infrared PT2L Digital No-Touch ThermometerAndon Health Co, Ltd.20200—
+4K200531iHealth Infrared No-Touch Forehead ThermometerAndon Health Co, Ltd.20201—
+5K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.20250—
+5K202753iHealth Wireless No-Touch Forehead ThermometerAndon Health Co, Ltd.20210—