510(k) Report

Devices descending from K970556

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984261Surestep Blood Glucose Monitoring SystemLifescan, Inc.199915—
+1K982303Precision PCX Point of Care Management System , QC Manager Data Manager System…Medisense, Inc.199814—
+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—
+2K022941Medisense Precision PCX Point of Care Management System for Blood Glucose TestingAbbott Laboratories200213—
+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—
+3K051802Freestyle Connect Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200501
+3K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200512—
+4K113192Healthpro Blood Glucose Monitoring SystemInfopia Co, Ltd.20121—
+4K051839Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc.2006102
+5K132862Healthpro Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.20130—
+5K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation20123—
+5K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22…Abbott Diabetes Care, Inc.20104Class I
+5K070850Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200741
+6K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation20130—
+6K122435Nova One Blood Glucose MonitorNova Biomedical Corporation20121—
+6K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose…Abbott Diabetes Care, Inc.20102Class I
+6K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+7K150332FreeStyle Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+7K150531FreeStyle Freedom Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+7K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation20130—