# K062058: Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare
- Decided: Sep 11, 2006 after 53 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 7 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K023657: Ascensia® CONTOUR® Diabetes Care System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K130181: Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose Monitoring System (2013), 6 descendants of its own
- K111268: Contour (R) Next Blood Glucose Monitoring System (2012), 6 descendants of its own
- K130265: Contour Next EZ Blood Glucose Meter (2014), 5 descendants of its own
- K132966: Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring System (2013), 4 descendants of its own
- K162336: Contour Next EZ Blood Glucose Monitoring System (2017), 2 descendants of its own

## Recalls of this device
- Aug 12, 2011 · Not classified · Z-3268-2011: All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour" USB blood glucose meters are being recalled a packaging issue whi
- Jun 6, 2007 · Not classified · Z-1001-2007: Incorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users.

## Indications for use
The Ascensia® CONTOUR® Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia® CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The Ascensia® CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples and neonatal blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, and in the case of neonates, the heel. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Source page: https://510kreport.com/device/K062058
Methodology: https://510kreport.com/methodology