510(k) Report

Devices descending from K020725

31 later devices reach Microlife Digital Infrared Ear Thermometer, Model IR1DE1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033820Microlife Digital Infrared Forehead Thermometer, Model FR1DM1Microlife Intellectual Property GmbH200423—
+1K034023Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1Microlife Intellectual Property GmbH20046—
+1K033818Microlife Digital Infrared Ear Thermometer, Models IR1DC1/V971, IR1DG1/SKU4289…Microlife Intellectual Property GmbH20040—
+1K033817Microlife Digital Infrared Ear Thermometer, Models IR1DA1-2, IR1DE1-2Microlife Intellectual Property GmbH20040—
+2K170219Microlife Digital Infrared Ear ThermometerMicrolife Intellectual Property GmbH20171—
+2K161728Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1Microfile Intellectual Property GmbH20161—
+2K113141Microlife Dual Mode Thermometer,Model IFR1MJ1Microlife Intellectual Property GmbH20121—
+2K100953Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH201018—
+2K091040Microlife Digital Infrared Ear Thermometer, Model Iridvi-1Microlife Intellectual Property GmbH20092—
+2K042906Amplife Digital Infrared Ear Thermometer, Model E101Amplife Corporation20040—
+3K191829Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH202011—
+3K182401B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared…Amzetta Technologies Private Limited20190—
+3K172874Infrared ThermometerShenzhen Jiacom Technology CO ., Ltd.20180—
+3K163256Dual Mode Infrared ThermometerIntelliworks, LLC20170—
+3K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+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—
+4K202741Infrared Forehead ThermometerShenzhen Combei Technology 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—
+4K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd.20192—
+4K190090DynoSense Vital Sign Measuring SystemDynosense Corp.20190—
+5K242876Pulse Oximeter ( PO2, PO2A, PO2B)Shenzhen Viatom Technology Co., Ltd.20250—
+5K222057ThermoclickT&R BIOFAB CO., Ltd.20230—
+5K213515WesperO2Wesper, Inc.20220—
+5K210171Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)Sichuan Youkede Medical Equipment Co.,Ltd20220—