510(k) Report

Devices descending from K063185

18 later devices reach Rii Infrared Ear Thermometer, Models TH5XY Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc.201714—
+1K102187Rii Infrared Ear Thermometer,Radiant Innovation, Inc.20100—
+1K070976Rii Infrared Ear Thermometer, Model TH01BNRadiant Innovation, Inc.20071—
+2K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd.20198—
+2K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.20183—
+2K180385Infrared Body ThermometerHetaida Technology Co., Ltd.20180—
+2K101253Rii Infrared Ear Thermometer, Model: TH60NRadiant Innovation, Inc.20100—
+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—
+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—
+3K190873Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.20192—
+4K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.20250—
+4K220276Infrared Thermometer TET-351Truly Instrument Limited20230—
+4K202481ThermArt (Model IR-EFT)Comper Chuangxiang (Beijing) Technology Co., Ltd.20210—
+4K202753iHealth Wireless No-Touch Forehead ThermometerAndon Health Co, Ltd.20210—