510(k) Report

Devices descending from K121428

20 later devices reach Non-Contact Clinical Thermometer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)Radiant Innovation, Inc.20240—
+1K173048No-contact Forehead ThermometerDongguan Simzo Electronic Technology Co., Ltd.20182—
+1K163601RII Smart IR ThermometerRadiant Innovation, Inc.20180—
+1K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.20183—
+1K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc.201714—
+2K223037Infrared Thermometer, Model: IR8807Shen Zhen Rong Feng Technology Co., Ltd.20230—
+2K210014Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)Guandong Genial Technology Co., Limited20210—
+2K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd.20198—
+2K190873Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.20192—
+2K180385Infrared Body ThermometerHetaida Technology Co., Ltd.20180—
+3K220276Infrared Thermometer TET-351Truly Instrument Limited20230—
+3K213011Infrared Thermometer (model: E201)Bioland Technology, Ltd.20221—
+3K213084Ear Thermometer, Model ET005, ET008, ET009Guangzhou Berrcom Medical Device Co., Ltd.20220—
+3K213079Ear Thermometer, Model ET001Guangzhou Berrcom Medical Device Co., Ltd.20220—
+3K202481ThermArt (Model IR-EFT)Comper Chuangxiang (Beijing) Technology Co., Ltd.20210—
+3K202440Infrared ThermometerShenzhen Sonida Digital Technology Co., Ltd.20210—
+3K200710Infrared PT2L Digital No-Touch ThermometerAndon Health Co, Ltd.20200—
+3K200531iHealth Infrared No-Touch Forehead ThermometerAndon Health Co, Ltd.20201—
+4K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.20250—
+4K202753iHealth Wireless No-Touch Forehead ThermometerAndon Health Co, Ltd.20210—