510(k) Report

Devices descending from K080923

22 later devices reach Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093475Basesens Blood Glucose Monitoring SystemHygeia, Inc.20100—
+1K083468Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B…I-Sens, Inc.200921—
+2K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc.20165—
+2K151658Gmate Origin Blood Glucose Monitoring SystemPhilosys, Inc.20150—
+2K141656Gmate Mini Blood Glucose Monitoring System, Gmate Step Blood Glucose Monitoring SystemPhilosys, Inc.20150—
+2K130696Caresens N Link Blood Glucose Monitoring System; Caresens N Link Multi Blood Blucose…I-Sens, Inc.20130—
+2K123007Veri-Q MGD-1001 Blood Glucose Monitoring System, Veri-Q Plus MGD-1001 Blood Glucose…Mico Biomed Co., Ltd.20130—
+2K123016Veri-Q Self-Testing and Veri-Q Plus MGD-2001 Blood Glucose Monitoring SystemsMico Biomed Co., Ltd.20130—
+2K121133Caresens N Voice Blood Glucose Monitoring SystemI-Sens, Inc.20121—
+2K120759Caresens N Mini Blood Glucose Monitoring System, Mini Blood Glucose Meter, Blood Glucose…I-Sens, Inc.20120—
+2K120351Caresens N Pop Blood Glucose Monitoring System Caresens N Pop Blood Glucose Meter…I-Sens, Inc.20120—
+2K103278Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura…I-Sens, Inc.20112—
+2K103396Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control SolutionI-Sens, Inc.20111—
+3K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemI-Sens, Inc.20170—
+3K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose…I-Sens, Inc.20173—
+3K132288Caresens N Voice Multi Blood Glucose Monitoring System, Caresens N Voice Multi Blood…I-Sens, Inc.20130—
+3K131419Acura Plus Multi Blood Glucose Monitoring SystemI-Sens, Inc.20131—
+3K121654Auto-Chek Blood Glucose Monitoring System, Meter, Test Strip. Auto-Check Control SolutionI-Sens, Inc.20120—
+4K230625ReliOn Premier BLU Blood Glucose Monitoring SystemI-Sens, Inc.20230—
+4K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood…I-Sens, Inc.20180—
+4K180866CareSens S Fit Blood Glucose Monitoring SystemI-Sens, Inc.20180—
+4K151164Assure Prism multi Blood Glucose Monitoring SystemI-Sens, Inc.20150—