510(k) · Cleared
ClearedAscensia Breeze Blood Glucose Meter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · CGA Glucose Oxidase, Glucose
Cleared on Mar 3, 2003 after an 84-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Mar 3, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK024062 Ascensia Breeze Blood Glucose MeterBayer Corp. · 2003
- Descendant · cites it directly · 3 of its ownK062347 Ascensia Breeze 2 Blood Glucose Monitoring SystemBayer Healthcare, LLC · 2006
- Descendant · 2 generations on · 1 of its ownK082395 Glucose Meter-Check Control Solution for Bayer Ascensia Blood…Bionostics, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK123966 Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK080273 AB-Trol and Private Label Glucose Control SolutionFujirebio Diagnostics Texas, Inc. · 2008
Most influential descendants
Showing 4 of 4 · See all- K062347Ascensia Breeze 2 Blood Glucose Monitoring SystemBayer Healthcare, LLC · 2006 · cites it directly3descendants
- K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc. · 2008 · 2 generations on1descendant
- K123966Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013 · 3 generations on0descendants
- K080273AB-Trol and Private Label Glucose Control SolutionFujirebio Diagnostics Texas, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024062 | Ascensia Breeze Blood Glucose Meter | Bayer Corp. | 2003 | — |
| +1 | K062347 | Ascensia Breeze 2 Blood Glucose Monitoring System | Bayer Healthcare, LLC | 2006 | — |
| +2 | K082395 | Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter… | Bionostics, Inc. | 2008 | — |
| +3 | K123966 | Glucose Meter-Check Solution for Bayer | Bionostics, Inc. | 2013 | — |
| +2 | K080273 | AB-Trol and Private Label Glucose Control Solution | Fujirebio Diagnostics Texas, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | ASCENSIA DEX 2 Blood Glucose Meter Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062347 | Ascensia Breeze 2 Blood Glucose Monitoring System | 2006 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K062347 (Bayer Healthcare, LLC, 2006) has gone furthest, with 3 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024062 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024062: Ascensia Breeze Blood Glucose Meter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024062
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026