# K111268: Contour (R) Next Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare
- Decided: Mar 6, 2012 after 307 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K062058 (2006). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062058: Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080, Bayer Healthcare (2006) Summary page 1.

## Most influential descendants
- K130265: Contour Next EZ Blood Glucose Meter (2014), 5 descendants of its own
- K162336: Contour Next EZ Blood Glucose Monitoring System (2017), 2 descendants 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
- K162203: POGO Automatic Blood Glucose Monitoring System (2017), 1 descendant of its own
- K210687: CONTOUR® NEXT ONE Blood Glucose Monitoring System (2021), 0 descendants of its own

## Recalls of this device
- Jun 22, 2015 · Class II · Z-2482-2015: If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by the blood g

## Indications for use
The CONTOURONEXT 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 CONTOUR NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program. The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for use for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. 'The CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The CONTOUR®NEXT control solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check.

Source page: https://510kreport.com/device/K111268
Methodology: https://510kreport.com/methodology