510(k) Report

Devices descending from K002134

73 later devices reach One Touch Ultra Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160179VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc.20174—
+1K113636Blood Glucose Monitoring System (Glucose Oxidase)Philosys Co., Ltd.20130—
+1K123010ON Call Vivid Blood Glucose Monitoring SystemACON Laboratories, Inc.20120—
+1K112653ON Call Vivid Blood Glucose Monitoring SystemsACON Laboratories, Inc.20127—
+1K111371ON Call Chosen Blood Glucose Monitoring SystemACON Laboratories, Inc.20110—
+1K090057ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co.200917—
+1K052108Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Sein Electronics Co., Ltd.20052—
+1K021819One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc.2002261
+1K012324Accu-Chek Active Test SystemRoche Diagnostics Corp.20017—
+1K011616Induo Blood Glucose MeterInverness Medical Innovations, Inc.20010—
+2K173140VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose…Vivachek Laboratories, Inc.20183—
+2K133584IN Touch Blood Glucose Monitoring SystemEoshealth, Inc.201401
+2K130284ON Call Sharp Blood Glucose Monitoring SystemACON Laboratories, Inc.20133—
+2K132086ON Call Express Blood Glucose Monitoring SystemACON Laboratories, Inc.20131—
+2K113332ON Call Chosen Lancing DeviceACON Laboratories, Inc.201216—
+2K080853Duo-Care Blood Glucose and Blood Pressure Monitor SystemGenexel-Sein, Inc.20090—
+2K080636Duo-Max Blood Pressure & Glucose Monitor HMF-100Hubdic Co., Ltd.20090—
+2K082020Envision Blood Glucose Test SystemInfopia Co, Ltd.20080—
+2K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.20082—
+2K080639Symphony Glucose Management SystemAnimas Corp.200827
+2K072369Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC200821—
+2K063026OK Meter Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20070—
+2K021827Modification to Accu-Chek Active SystemRoche Diagnostics Corp.200211
+2K021448Modification to Accu-Chek Active SystemRoche Diagnostics Corp.20022—
+3K233058VivaChek Link Plus Blood Glucose Monitoring SystemVivachek Biotech (Hangzhou) Co., Ltd.20231—
+3K223722MIO Blood Glucose Monitoring SystemMio Labs, Inc.20230—
+3K222656LDE4 Lancing DeviceI-Sens, Inc.20220—
+3K221062RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing DeviceBionime Corporation20221—
+3K221970Lancing deviceSteriLance Medical (Suzhou), Inc.20222—
+3K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T…Tianjin Huahong Technology Co., Ltd.20227—
+3K193340GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring SystemMicrotech Medical, Inc.20200—
+3K181527On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring…ACON Laboratories, Inc.20181—
+3K163087PixoTest Blood Glucose Monitoring SystemIxensor Company, Ltd.20170—
+3K153670Genteel Lancing DeviceGenteel, LLC20163—
+3K151595On Call Express Pro Blood Glucose Monitoring SystemACON Laboratories, Inc.20150—
+3K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc.20131—
+3K113764Glucose Meter-Check Solution for InfopiaBionostics, Inc.20120—
+3K103021Element Plus Blood Glucose Monitoring SystemInfopia Co, Ltd.20113—
+3K082275Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023Infopia Co, Ltd.20102—
+3K090405Lipidpro SystemInfopia Co, Ltd.20091—
+3K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+3K081703Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd.200910—
+3K082590Symphony Meter RemoteLifescan, Inc.20080—
+4K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)SteriLance Medical (Suzhou), Inc.20260—
+4K250813MICROLET®NEXT 2 Lancing DeviceAscensia Diabetes Care U.S., Inc.20250—
+4K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.20250—
+4K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing…Tianjin Huahong Technology Co., Ltd.20243—
+4K242622Sterile Lancets for Single UseNingbo Caremed Medical Products Co., Ltd.20240—
+4K232330Lancing SystemNingbo Medsun Medical Co., Ltd.20240—
+4K231797Medifun Lancing Device, Model No. LD-E1Medifun Corporation20230—
+4K223643Verifine® Ease Lancing Device, Verifine® Lancing DevicePromisemed Hangzhou Meditech Co., Ltd.20230—
+4K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd.20220—
+4K200277Livongo Blood Glucose Monitoring System (BG1000)Livongo Health, Inc.20200—
+4K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.20160—
+4K143169MyGlucoHealth Wireless SystemEntra Health Systems20160—
+4K132406Elementv Blood Glucose Monitoring SystemInfopia Co, Ltd.20140—
+4K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd.20130—
+4K121366Hemocue HBA1C 501Infopia Co, Ltd.20121—
+4K113670Element Blood Glucose Monitoring SystemInfopia Co, Ltd.20121—
+4K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.20118—
+5K262135Lancing deviceTianjin Huahong Technology Co., Ltd.20260—
+5K262211LancetTianjin Huahong Technology Co., Ltd.20260—
+5K253706Lancing device (HH-XV-T)Tianjin Huahong Technology Co., Ltd.20250—
+5K152124Tempus IC2Remote Diagnostics Technologies, Ltd.20157—
+5K141750Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring SystemInfopia Co, Ltd.20140—
+5K133045Element TM Lite Blood Glucose Monitoring SystemInfopia Co, Ltd.20140—
+6K152645Dictum HealthDictum Health, Inc.20166—
+7K170798Dictum HealthDictum Health, Inc.20175—
+8K192004Eko Analysis SoftwareEko Devices, Inc.20204—
+9K213794Eko Murmur Analysis Software (EMAS)Eko Devices, Inc.20223—
+10K251494Eko Foundation Analysis Software with Transformers (EFAST)Eko Health, Inc.20250—
+10K240901StethophoneSparrow Acoustics, Inc.20241—
+11K252595Stethophone ProSparrow Acoustics, Inc.20250—