510(k) Report

Devices descending from K994433

39 later devices reach Connect Data Management System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062434Zero-Click Data Management System, Model 8000-01528Agamatrix200614—
+1K020866Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc.200222—
+1K012014Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200123—
+2K111874Freestyle Insulinx Blood Glucose Monitoring SystemsAbbott Laboratories20122—
+2K100937PC Care Blood Glucose Data Management SoftwareI-Sens, Inc.20101—
+2K101597Wavesense Diabetes Manager Model Version 1.3.4Agamatrix201011—
+2K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22…Abbott Diabetes Care, Inc.20104Class I
+2K051839Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc.2006102
+2K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200512—
+2K031260Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System…Abbott Diabetes Care, Inc.200318—
+3K132821Agamatrix Health ManagerAgamatrix, Inc.20130—
+3K123136Genesis Health Record System, (GHRS)Genesis Health Technologies20130—
+3K120568Freestyle Insulinx Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20121Class I
+3K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation20123—
+3K103544Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application, Rev DAgamatrix, Inc.20119—
+3K083549Abt Glucose Control SolutionAmerican Biological Technologies, Inc.20082—
+3K071433SMS Glucose Control, Model 2120059Specialty Medical Supplies20070—
+3K070850Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200741
+3K060481Liberty Glucose Control SolutionLiberty Healthcare Group, Inc.20064—
+3K051802Freestyle Connect Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.200501
+4K152365AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring SystemAgamatrix, Inc.20161—
+4K152328FreeStyle InsuLinx Blood Glucose Monotioring SystemAbott Laboratories20150—
+4K131230Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc.20144—
+4K130535Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager ApplicationAgamatrix, Inc.20131—
+4K122688Nova Max Mini Blood Glucose and B-Ketone MonitorNova Biomedical Corporation20130—
+4K122435Nova One Blood Glucose MonitorNova Biomedical Corporation20121—
+4K102260Fdi Glucose Control SolutionsFujirebio Diagnostics,Inc.20101—
+4K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose…Abbott Diabetes Care, Inc.20102Class I
+4K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+5K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc.20160—
+5K150817Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.201521
+5K150299Gmate SMART Blood Glucose Monitoring SystemPhilosys, Inc.20150—
+5K150332FreeStyle Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+5K150531FreeStyle Freedom Lite Blood Glucose Monitoring SystemAbbott Laboratories20150—
+5K132148S HealthSamsung Electronics Co., Ltd.20130—
+5K131013Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring SystemNova Biomedical Corporation20130—
+5K103450Fdi Glucose Control Solution for FreestyleFujirebio Diagnostics,Inc.20110—
+6K172723Dario LC Blood Glucose Monitoring SystemLabstyle Innovation, Ltd.20180—
+6K163159Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.20170—