510(k) Report

Devices descending from K011059

48 later devices reach Infared Ear Thermometer, Model TH8 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180387Infrared Ear ThermometerHetaida Technology Co., Ltd.20190—
+1K103097Infrared Ear ThermometerRadiant Innovation, Inc.20104—
+1K102187Rii Infrared Ear Thermometer,Radiant Innovation, Inc.20100—
+1K101264Tempus IC Professional Patient MonitorRemote Diagnostic Technologies, Ltd.2010161
+1K081788Infrared Ear Thermometer, Models Innotherm Ict-100 and Ict-200Innochips Technology Co., Ltd.20081—
+1K040377Rii Infrared Ear Thermometer, Models Thxxn SeriesRadiant Innovation, Inc.200420—
+1K030324Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 SeriesRadiant Innovation, Inc.200321—
+1K020504Infrared Ear Thermometer, Models TH88 SeriesRadiant Innovation, Inc.20020—
+2K130773Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.201361
+2K113833Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20123—
+2K111703Infrared Ear TherometerFudakang Industrial Co., Ltd.20120—
+2K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.20118—
+2K051269Rii Infrared Ear Thermometer, Models TH00XY SeriesRadiant Innovation, Inc.200519—
+3K170567Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20172—
+3K153135Vital Signs MonitorGuangdong Biolight Meditech Co., Ltd.20162—
+3K152124Tempus IC2Remote Diagnostics Technologies, Ltd.20157—
+3K133973Tempus Pro with Enhanced FeaturesRemote Diagnostic Technologies, Ltd.20143—
+3K134014Tempus Pro Accessories (Ultrasound & Video Laryngoscope Probe)Remote Diagnostic Technologies, Ltd.20143—
+3K133988Tempus Pro Extended FeaturesRemote Diagnostic Technologies, Ltd.20143—
+3K063185Rii Infrared Ear Thermometer, Models TH5XY SeriesRadiant Innovation, Inc.200618—
+4K181919Patient MonitorGuangdong Biolight Meditech Co., Ltd.20190—
+4K173768Tempus Pro Patient MonitorRemote Diagnostic Technologies, Ltd.20181—
+4K170538RVS-100 Vital Signs MonitorRudolf Riester GmbH20170—
+4K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc.201714—
+4K152645Dictum HealthDictum Health, Inc.20166—
+4K070976Rii Infrared Ear Thermometer, Model TH01BNRadiant Innovation, Inc.20071—
+5K201746Tempus Pro Patient MonitorRemote Diagnostic Technologies Limited202007
+5K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd.20198—
+5K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.20183—
+5K180385Infrared Body ThermometerHetaida Technology Co., Ltd.20180—
+5K170798Dictum HealthDictum Health, Inc.20175—
+5K101253Rii Infrared Ear Thermometer, Model: TH60NRadiant Innovation, Inc.20100—
+6K213011Infrared Thermometer (model: E201)Bioland Technology, Ltd.20221—
+6K213084Ear Thermometer, Model ET005, ET008, ET009Guangzhou Berrcom Medical Device Co., Ltd.20220—
+6K213079Ear Thermometer, Model ET001Guangzhou Berrcom Medical Device Co., Ltd.20220—
+6K202440Infrared ThermometerShenzhen Sonida Digital Technology Co., Ltd.20210—
+6K200710Infrared PT2L Digital No-Touch ThermometerAndon Health Co, Ltd.20200—
+6K200531iHealth Infrared No-Touch Forehead ThermometerAndon Health Co, Ltd.20201—
+6K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+6K190873Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.20192—
+7K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.20250—
+7K220276Infrared Thermometer TET-351Truly Instrument Limited20230—
+7K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+7K202481ThermArt (Model IR-EFT)Comper Chuangxiang (Beijing) Technology Co., Ltd.20210—
+7K202753iHealth Wireless No-Touch Forehead ThermometerAndon Health Co, Ltd.20210—
+8K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+8K240901StethophoneSparrow Acoustics, Inc.20241—
+9K252595Stethophone ProSparrow Acoustics, Inc.20250—