# K043158: Ascensia Brio Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 22, 2004 after 37 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ASCENSIA ELITE Diabetes Care System: named in the summary without a submission number

## Indications for use
The Ascensia BRIO™ Blood Glucose Meter is used with Ascensia® EASYFILL™ Blood Glucose Test Strips and ASCENSIA® EASYFILL™ CONTROL SOLUTIONS (Low, Normal, and High) for the measurement of glucose in whole blood. The Ascensia BRIO™ 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® BRIO™ Blood Glucose Monitoring System is indicated for use with fingertip capillary whole blood specimens. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Source page: https://510kreport.com/device/K043158
Methodology: https://510kreport.com/methodology