# K191286: CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System - Pathway: 510(k) (Special) - Applicant: Ascensia Diabetes Care - Decided: Nov 8, 2019 after 179 days - Product code: NBW (System, Test, Blood Glucose, Over The Counter) - Device class: 2 - Regulation: 21 CFR 862.1345 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 7 generations back to K030531 (2003). 17 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 19 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K160430: Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System, Ascensia Diabetes Care U.S., Inc. (2016) Summary page 8. - K150942: Contour Next USB Blood Glucose Monitoring System, Bayer Healthcare (2015) Summary page 8. - K160682: CONTOUR NEXT ONE Blood Glucose Monitoring System, Ascensia Diabetes Care (2016) Summary page 8. - K162336: Contour Next EZ Blood Glucose Monitoring System, Ascensia Diabetes Care U.S., Inc. (2017) Summary page 8. ## Most influential descendants - K210687: CONTOUR® NEXT ONE Blood Glucose Monitoring System (2021), 0 descendants of its own ## Indications for use The CONTOUR® NEXT EZ Blood Glucose Monitoring System is an over the counter (OTC) device utilized for self-testing by persons with diabetes at home for the quantitative measurement of glucose in whole blood, is for single-patient use only, and should not be shared. The system is intended for self testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The CONTOUR® NEXT EZ Blood Glucose Monitoring System is indicated for use with fresh fingertip capillary whole blood samples. The CONTOUR® NEXT EX EZ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT EZ blood glucose meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The CONTOUR® NEXT Blood Glucose Monitoring System is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only, and should not be shared. The system is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The CONTOUR® NEXT Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The system consists of a CONTOUR® NEXT blood glucose meter, CONTOUR® NEXT test strips and CONTOUR® NEXT control solutions. CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples. The CONTOUR® NEXT Blood Glucose Monitoring System is not intended for the diagnosis or screening for diabetes mellitus and its not intended for use on neonates. The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The System is intended for self-testing outside the body (in vitro diagnostic use) and is to be used as an aid to monitor the effectiveness of diabetes control. The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples. The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is intended to be used to transmit glucose values to Medtronic MiniMed Paradigm Insulin Pumps or Medtronic MiniMed Paradigm REAL-Time Revel Insulin Pumps or Medtronic MiniMed 530G Insulin Pumps and facilitate transfer of information to Medtronic MiniMed Carelink Therapy Management Software through use of radio frequency communication. The CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The CONTOUR® NEXT ONE Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The CONTOUR® NEXT ONE Blood Glucose Monitoring System should be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The CONTOUR® NEXT test strips are for use with the CONTOUR® NEXT ONE blood glucose meter to quantitatively measure glucose in fresh capillary whole blood draw from the fingertips or palm. The system is intended for in vitro diagnostic use only. The CONTOUR® NEXT USB Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The system consists of a CONTOUR® NEXT USB blood glucose meter, CONTOUR® NEXT test strips and CONTOUR® NEXT control solutions. The CONTOUR® NEXT USB Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The CONTOUR® NEXT USB Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. The CONTOUR® NEXT Test Strips are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System for the quantitative measurement of glucose in whole blood. Source page: https://510kreport.com/device/K191286 Methodology: https://510kreport.com/methodology