510(k) Report

Devices descending from K011291

200 later devices reach Temporalscanner Thermometer, Sensortouch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200159Non-contact Infrared Body Thermometer, model:HTD8823USHetaida Technology Co., Ltd.20210—
+1K200781Infrared Body ThermometerHeitaida Technology Co., Ltd.20200—
+1K200434V20, V20a, AVSM3 SNFMediana Co., Ltd.202001
+1K191697Cardiac Monitor 1500Zynex Medical, Inc.20201—
+1K182821Accutorr 7/VS-900/VS-900c Vital Signs MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd.201901
+1K161909IQvitals ZoneMidmark Corporation201614
+1K152043Diagnostic Station DS20Schiller AG20161—
+1K133961Suresigns VS3, Suresigns VS4Philips Medical Systems20143—
+1K140430740 SelectCas Medical Systems, Inc.20141—
+1K111463Valeo VT-601 Series IR ThermometerValeo Corp.20121—
+1K113165Mini-MedicAthena Gtx201213—
+1K101912The Infrared Forehead Thermometer, Model FS-300&301Hubdic Co., Ltd.20102—
+1K102426Carescape Model V100 Vital Signs MonitorGe Medical Systems Information Technologies201011—
+1K090386Non-Invasive Infrared (Nir)Medisim, Ltd.20101—
+1K033790Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L.200480—
+1K032362UP-Grade Forehead ThermometerMedisim, Ltd.20035—
+1K031503Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation200367—
+2K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation20260—
+2K223217Zynex Monitoring System, Model CM-1600Zynex Medical, Inc.20230—
+2K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH201903
+2K190792BB-613WPBiobeat Technologies, Ltd.201912—
+2K172894Infrared ThermometerShenzhen Jiacom Technology CO ., Ltd.20180—
+2K170182Cardiovit FT-1Schiller AG20170—
+2K152659V10Mediana Co., Ltd.20162—
+2K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems20152—
+2K151071SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie Sas20153—
+2K150620740 SelectCas Medical Systems, Inc.201501
+2K133810VC150 Vital Signs MonitorInnokas Yhtyma201433
+2K131155UGFT3; FHT7Medisim, Ltd.20130—
+2K130361Thermofinder; ThermocareHubdic Co., Ltd.20130—
+2K111703Infrared Ear TherometerFudakang Industrial Co., Ltd.20120—
+2K103839Behind Ear Gentle Touch ThermometerKaz, Inc.20111—
+2K092958Avita Scaneo IR Thermometer, Models TS2X & TS3X SeriesAvita Corporation20090—
+2K081160Avita Radar Thermo IR Thermometer, NT1 SeriesAvita Corporation200838—
+2K072108Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L.200740—
+2K070491Digital Forehead Thermometer, Model# KD-2200K-Jump Health Co., Ltd.20071—
+2K052849Infrared Thermometer, Fdir-V1Famidoc Technology Co., Ltd.200524—
+2K051422Dual Mode UP-Grade Forehead/Underarm Thermometer DeviceMedisim, Ltd.20051—
+2K050463Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110 Ear/Skin/Surface IR…Taidoc Technology Corporation200540—
+3K250415G0 Blood Pressure Monitoring System (G0)Aktiia SA20251—
+3K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+3K233810Portrait VSMGe Medical Systems Information Technologies, Inc.202401
+3K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+3K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc.20232—
+3K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc.202226
+3K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+3K170497V10Mediana Co., Ltd.201711
+3K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring…Capsule Technologie Sas20172—
+3K163649SureSigns VS3; SureSigns VS4Philips Medical Systems2017110
+3K161933The Braun ThermoScan® 3 High Speed Compact Ear ThermometerKaz USA, Inc., A Helen of Troy Company20160—
+3K134043NO Touch+Forehead NTF 3000 ThermometerKaz USA, Inc (A Subsidiaryof Kaz Inc)201436—
+3K113761Infrared ThermometerFamidoc Technology Co., Ltd.20127—
+3K121428Non-Contact Clinical ThermometerRadiant Innovation, Inc.201220—
+3K103617Digital Forehead ThermometerK-Jump Health Co., Ltd.201101
+3K100488IR Ear/Forehead Thermometer Mode DX6635, DX6637, DTH1081Shenzhen Dongdixin Technology Co., Ltd.201001
+3K101736Non-Contact Forehead Infrared Thermometer, Model DT-8806H, Body Infrared Thermometer…Shenzhen Everbest Machinery Industry Co., Ltd.20103—
+3K100953Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH201018—
+3K092959Avita Radar Thermo IR Thermometer, Model NT 152Avita Corporation20090—
+3K080759Thermoflash LX-26Jxb Co. Ltd Guangzhou (China)20089—
+3K062445Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd.200739—
+4K254000Happy Health Blood Pressure MonitorHappy Health, Inc.20260—
+4K253152BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)Biozen, LLC20260—
+4K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.20250—
+4K242352Accurate Mini Non-invasive blood pressure monitor (AMB-001)Accurate Meditech, Inc.20250—
+4K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+4K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)Radiant Innovation, Inc.20240—
+4K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+4K203170Infrared Thermometer Models: DT-8806S, DT-8807SShenzhen Everbest Machinery Industry Co., Ltd.20211—
+4K191829Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH202011—
+4K191668Infrared Forehead Thermometer (Model IR-FT)Comper Chuangxiang (Beijing) Technology Co., Ltd.20191—
+4K190468Nihon Kohden SVM-7200 Series Vital Signs MonitorNihon Kohden Corporation20190—
+4K190242Tyto ThermometerTyto Care, Ltd.20191—
+4K173048No-contact Forehead ThermometerDongguan Simzo Electronic Technology Co., Ltd.20182—
+4K163601RII Smart IR ThermometerRadiant Innovation, Inc.20180—
+4K180207Non-contact Infrared ThermometerAlicn Medical (Shenzhen), Inc.20180—
+4K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd.20183—
+4K180734SmartLinx Vitals Plus Patient Monitoring SystemCapsule Technologie20180—
+4K171214Infrared ThermometerShenzhen Brav Electronic Technologies Co., Ltd.20186—
+4K170662Non Contact Infrared Forehead ThermometerIntrinity Global Limited201710—
+4K163516Braun No Touch + Forehead NTF3000 ThermometerKaz USA, Inc., A Helen of Troy Company201716—
+4K162509Infrared Non-contact Thermometer, Model ACT8100Easywell Biomedicals, Inc.20170—
+4K160358DT-100Mediana Co., Ltd.20170—
+4K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc.201714—
+4K161735Non-contact Forehead ThermometerShenzhen Dongdixin Technology Co., Ltd.20160—
+4K160544Withings Thermo (Model SCT01)Withings20161—
+4K150869Checkme Pro Health MonitorViatom Technology Co., Ltd.20155—
+4K102947Non-Contact Infrared ThermometerK-Jump Health Co., Ltd.20118—
+4K081256Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd.200838—
+5K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+5K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+5K252474Withings BeamO (SCT02)Withings20250—
+5K223037Infrared Thermometer, Model: IR8807Shen Zhen Rong Feng Technology Co., Ltd.20230—
+5K223785N9+Nonagon, Ltd.20230—
+5K220657Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)Zhejiang Rongsheng Industrial Co., Ltd.20230—
+5K221800Infrared Thermometer (Model: Y20001, Y20002)Zhangzhou Easepal Medical Science and Technology Co., Ltd.20220—
+5K213038Infrared Forehead Thermometer, model: HS-9802DJiaxing Shangjia Intelligence Technology Co., Ltd.20220—
+5K211776Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)Microlife Intellectual Property GmbH20221—
+5K211752Infrared ThermometerBeijing Choice Electronic Technology Co., Ltd.20220—
+5K201600Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27…Kangfu Medical Equipment Factory20210—
+5K211744Non-Contact Infrared Thermometer, model HL710HHealth & Life Co., Ltd.20210—