510(k) · Cleared
ClearedAscensia Contour Blood Glucose Meter, Model 7151; Ascensia Microfill Reagent Strip, Model 7080
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Apr 12, 2006 after a 48-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Apr 12, 2006
- Review
- 48 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK060470 Ascensia Contour Blood Glucose Meter, Model 7151; Ascensia Microfill…Bayer Healthcare · 2006
- Descendant · cites it directly · 0 of its ownK090628 Didget Blood Glucose Meter, Model 6181; Contour Blood Glucose Test…Bayer Healthcare, LLC · 2009
Most influential descendants
Showing 1 of 1 · See all- K090628Didget Blood Glucose Meter, Model 6181; Contour Blood Glucose Test Strips, Model 7080Bayer Healthcare, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060470 | Ascensia Contour Blood Glucose Meter, Model 7151; Ascensia Microfill Reagent… | Bayer Healthcare | 2006 | — |
| +1 | K090628 | Didget Blood Glucose Meter, Model 6181; Contour Blood Glucose Test Strips… | Bayer Healthcare, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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…Classification Code - 75 LER, Glucose Dehydrogenase, Glucose Predicate Devices: Ascensia® CONTOURO Diabetes Care System, K023657 Device Description; The Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip) is use… |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090628 | Didget Blood Glucose Meter, Model 6181; Contour Blood Glucose Test Strips, Model 7080 | 2009 | 0 |
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, K090628 (Bayer Healthcare, LLC, 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060470 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060470: Ascensia Contour Blood Glucose Meter, Model 7151; Ascensia Microfill Reagent Strip, Model 7080.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060470
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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