# K062347: Ascensia Breeze 2 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Nov 22, 2006 after 104 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
Longest line of descent: 1 generation back to K024062 (2003). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K024062: Ascensia Breeze Blood Glucose Meter, Bayer Corp. (2003) Summary page 1.

## Most influential descendants
- 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®2 Blood Glucose Monitoring System consisting of the Ascensia® BREEZE@2 Blood Glucose Meter, Ascensia® BREEZE®2 Reagent Strips and Ascensia ® BREEZE®2 Control Solution is for the measurement of glucose in whole blood. The Ascensia® BREEZE@2 Blood Glucose Monitoring System allows the user an option to use the palm and forearm in addition to the fingertip (testing) to collect capillary blood for self-monitoring of blood glucose within certain conditions as explained in the labeling. Ascensia® BREEZE®2 Blood Glucose MonitoringSystem is an over-the-counter (OTC) device used by persons with diabetes. Ascensia BREEZE®2 Blood Glucose Monitoring System is not for use with neonatal blood specimens. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Source page: https://510kreport.com/device/K062347
Methodology: https://510kreport.com/methodology