# K060470: Ascensia Contour Blood Glucose Meter, Model 7151; Ascensia Microfill Reagent Strip, Model 7080

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare
- Decided: Apr 12, 2006 after 48 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K090628: Didget Blood Glucose Meter, Model 6181; Contour Blood Glucose Test Strips, Model 7080 (2009), 0 descendants of its own

## 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. Capillary samples may be drawn from the fingertip, palm, forearm, abdomen and thigh. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Source page: https://510kreport.com/device/K060470
Methodology: https://510kreport.com/methodology