# K121087: Contour Next Usb Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Bayer Healthcare
- Decided: Jun 28, 2012 after 79 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: 4 generations back to K030531 (2003). 7 ancestors in all.
10 later devices descend from it; 1 cites 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)
- K110894: Contour Next Link Wireless Blood Glucose Meter, Bayer Healthcare (2012)

## Most influential descendants
- K150942: Contour Next USB Blood Glucose Monitoring System (2015), 9 descendants of its own
- 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

## 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 CONTOUR® NEXT USB Blood Glucose Monitoring System is indicated for use with fresh capillarl whole blood samples. drawn from the fingertip and palm only. The CONTOUR NEXT USB Blood Glucose Monitoring System may be used as an aid to monitor the effectiveness of a diabetes control program and is not intended for the diagnosis of or sRen 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. The Contour® NEXT Controls are for use with the CONTOUR® NEXT USB Blood Glucose Monitoring System to check that the meter and test strips are w orking properly. Glucofacts® Deluxe Diabetes Management Software is an over-the-counter software program intended for use by health care professionals and patients with diabetes for viewing and printing reports that display blood sugar readings from Bayer's Contour and Breeze families of meters.

Source page: https://510kreport.com/device/K121087
Methodology: https://510kreport.com/methodology