# K024062: Ascensia Breeze Blood Glucose Meter

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Mar 3, 2003 after 84 days
- Product code: CGA (Glucose Oxidase, Glucose)
- 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices 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 DEX 2 Blood Glucose Meter: named in the summary without a submission number

## Most influential descendants
- K062347: Ascensia Breeze 2 Blood Glucose Monitoring System (2006), 3 descendants of its own
- K082395: Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002 (2008), 1 descendant of its own
- K123966: Glucose Meter-Check Solution for Bayer (2013), 0 descendants of its own
- K080273: AB-Trol and Private Label Glucose Control Solution (2008), 0 descendants of its own

## Indications for use
The ASCENSIA BREEZE Blood Glucose Meter is used with the ASCENSIA AUTODISC Blood Glucose Test Strips and ASCENSIA AUTODISC CONTROLS for the measurement of glucose in whole blood. The ASCENSIA BREEZE Blood Glucose Meter is a n Over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings. The ASCENSIA BREEZE Blood Glucose System is indicated for use with venous, and capillary whole blood samples 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/K024062
Methodology: https://510kreport.com/methodology