510(k) Report

Devices descending from K942455

16 later devices reach Lifescan Surestep Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984261Surestep Blood Glucose Monitoring SystemLifescan, Inc.199915—
+2K082201G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc.20091—
+2K061431Easygluco, Model Igm-0002 G2U. S. Diagnostics, Inc.20070—
+2K052469GlucopackHealthpia America Corp.20061—
+2K051651G4, Model Igm-0004U. S. Diagnostics, Inc.20060—
+2K051285Glucolab Blood Glucose Monitoring SystemInfopia Co, Ltd.20056—
+2K043512Easygluco Igm-0002 G2American Healthcare, Inc.20050—
+2K043543Blood Glucose Monitoring SystemAmerican Healthcare, Inc.20050—
+2K031501Easygluco, Model IGM0002American Healthcare, Inc.20030—
+3K110435Easygluco Plus Blood Glucose Monitoring SystemU. S. Diagnostics, Inc.20110—
+3K091168Glucophone Blood Glucose Test System, Model Igm-0025Infopia Co, Ltd.20100—
+3K091157Gluco Lab Auto Coding, Model Igm-0022Infopia Co, Ltd.20092—
+3K090712Eocene SystemInfopia Co, Ltd.20090—
+3K080636Duo-Max Blood Pressure & Glucose Monitor HMF-100Hubdic Co., Ltd.20090—
+4K113192Healthpro Blood Glucose Monitoring SystemInfopia Co, Ltd.20121—
+5K132862Healthpro Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.20130—