510(k) Report

Devices descending from K042005

26 later devices reach Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060467Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc.200617—
+1K053593ProdigyDiagnostic Devices, Inc.20063—
+1K061073Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement System, Model TD-3250Taidoc Technology Corporation20063—
+2K160038UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd.20161—
+2K113077Bioland G-423 Glood Glucose Monitoring SystemTaidoc Technology Corporation20122—
+2K073118Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc.200814—
+2K062800Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/ Clever…Taidoc Technology Corporation20072—
+3K191657Bioland Blood Glucose Monitoring SystemBioland Technology, Ltd.20201—
+3K162430UniStrip1 Generic Blood Glucose Test StripsOk Biotech Co., Ltd.20170—
+3K122340Prodigy ChoiceProdigy Diabetes Care, LLC20130—
+3K122338Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC20133—
+3K092875Echo TD-3227 Dual Blood Pressure/Blood Glucose MeterTaidoc Technology Corporation20100—
+3K090609Okmeter Match Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20101—
+3K091815Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp.20096—
+3K080014Clever Chek TD-3250C Blood Glucose Plus Blood Pressure Monitoring SystemTaidoc Technology Corporation20080—
+4K202739Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose…Bioland Technology, Ltd.20220—
+4K142785PRODIGY iConnect Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20150—
+4K141914Prodigy Autocode Eject Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20151—
+4K132633Okmeter Direct Blood Glucose Monitoring SystemOk Biotech Co., Ltd.20140—
+4K122525Smartest Glucowise Blood Glucose Monitoring System, and Smartest Glucoswise Multi Blood…Biotest Medical Corp.20130—
+4K100560Easy Talk Blood Glucose Monitoring System Model: 6277Biotest Medical Corp.20101—
+4K100701Smartest Persona Blood Glucose Test Sytem Model: 6277Biotest Medical Corp.20100—
+4K093764SOLOV2 Blood Glucose Monitoring SystemBiotest Medical Corp.20101—
+5K152599PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose…Ok Biotech Co., Ltd.20160—
+5K133509Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi Blood Glucose Monitoring…Biotest Medical Corp.20140—
+5K123559Solusmobile Blood Glucose Managment SystemBiotest Medical Corp.20130—