# K150942: Contour Next USB Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Bayer Healthcare
- Decided: Nov 25, 2015 after 231 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). 8 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121087: Contour Next Usb Blood Glucose Monitoring System, Bayer Healthcare (2012) Summary page 4.

## Most influential descendants
- K160682: CONTOUR NEXT ONE Blood Glucose Monitoring System (2016), 8 descendants of its own
- K193407: Contour® next GEN Blood Glucose Monitoring System (2021), 5 descendants of its own
- K223293: CONTOUR® NEXT GEN Blood Glucose Monitoring System (2022), 2 descendants of its own
- K241787: CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System (2024), 1 descendant of its own
- 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

## Indications for use
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/K150942
Methodology: https://510kreport.com/methodology