510(k) Report

Devices descending from K081445

13 later devices reach Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121118Fora Comfortscan Ear ThermometerForacare, Inc.20120—
+1K120712Fora Comfortscan Ear ThermometerTaidoc Technology Corporation20120—
+1K113159U-Right TD-1240 ThermometerTaidoc Technology Corporation20127—
+1K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation20101—
+1K100942U-Right Ear Themometer, Models TD-1115 and TD-1118Taidoc Technology Corporation20100—
+2K172221VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100Taidoc Technology Corporation20180—
+2K132457Fora Diamond Nexus Mini Infrared Forehead ThermometerBiocare Asia Corporation, Ltd.20140—
+2K131771Caregiver Professional Clinical Thermometer, Pro-TF SeriesThermomedics, Inc.20132—
+2K122221Nexus IR30 Non-Contact Infrared Forehead ThermometerTaidoc Technology Corporation20132—
+3K200946Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)Taidoc Technology Corporation20220—
+3K180298welloStationXWello, Inc.20180—
+3K160802Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd.20160—
+3K133113Kingtech Forehead ThermometerKingtech Enterprise, Ltd.20130—