510(k) Report

Devices descending from K053529

34 later devices reach Onetouch Ultra 2 Blood Glucose Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123090GLB Benecheck Premium Glu Monitoring SystemGeneral Life Biotechnology Co., Ltd.20130—
+1K111456Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd.20122—
+1K093745One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc.20119—
+1K082513Onetouch Vita Blood Glucose Monitoring SystemLifescan, Inc.20080—
+1K080639Symphony Glucose Management SystemAnimas Corp.200827
+1K073231Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc.200815—
+2K152534Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose…Tianjin Empecs Medical Device Co., Ltd.20170—
+2K133260Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd.20140—
+2K120708Onetouch Verio Sync Blood Glucose Monitoring SystemCilag GmbH International20130—
+2K110587Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control…Bayer Healthcare, LLC20120—
+2K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare201213—
+2K110637Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International201171
+2K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090—
+2K082590Symphony Meter RemoteLifescan, Inc.20080—
+3K122370Contour Next Link Wireless Blood Glucose MonitorBayer Healthcare20133—
+3K131363Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International20136—
+3K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare201210—
+4K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose…Ascensia Diabetes Care U.S., Inc.20162—
+4K151611OneTouch Ultra Plus Flex Blood Glucose Monitoring SystemLifescan Europe20150—
+4K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare20159—
+4K150214OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe20154—
+5K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH20201—
+5K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose…Ascensia Diabetes Care20191—
+5K173658Confidence Blood Glucose Monitoring SystemApplied Biomedical, LLC20180—
+5K162564Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring…Tianjin Empecs Medical Device Co., Ltd.20170—
+5K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care20168—
+6K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.20240—
+6K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care202151
+6K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care20210—
+7K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemAscensia Diabetes Care20240—
+7K231476TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring SystemSinocare, Inc.20230—
+7K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.20222—
+8K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…Ascensia Diabetes Care U.S., Inc.20241—
+9K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…Ascensia Diabetes Care20260—