# K160430: Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Ascensia Diabetes Care U.S., Inc.
- Decided: Jun 24, 2016 after 129 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: 5 generations back to K030531 (2003). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122370: Contour Next Link Wireless Blood Glucose Monitor, Bayer Healthcare (2013) Summary page 5.
- K121190: Contour Next Blood Glucose Meter, Bayer Healthcare, LLC (2012) Summary page 5.

## Most influential descendants
- 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 (2019), 1 descendant of its own
- K210687: CONTOUR® NEXT ONE Blood Glucose Monitoring System (2021), 0 descendants of its own

## Indications for use
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 is 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.

Source page: https://510kreport.com/device/K160430
Methodology: https://510kreport.com/methodology