510(k) · Cleared
ClearedContour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System
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 Aug 26, 2009 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 18 later devices descend from it.
- Decided
- Aug 26, 2009
- Review
- 69 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 3 citing it directly.
- This deviceK091820 Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts…Bayer Healthcare · 2009
- Descendant · cites it directly · 13 of its ownK110894 Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012
- Descendant · 2 generations on · 10 of its ownK121087 Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012
- Descendant · 3 generations on · 9 of its ownK150942 Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015
- Descendant · 4 generations on · 8 of its ownK160682 CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2016
- Descendant · 5 generations on · 5 of its ownK193407 Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012 · cites it directly13descendants
- K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012 · 2 generations on10descendants
- K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015 · 3 generations on9descendants
- K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2016 · 4 generations on8descendants
- K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091820 | Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux… | Bayer Healthcare | 2009 | — |
| +1 | K110894 | Contour Next Link Wireless Blood Glucose Meter | Bayer Healthcare | 2012 | — |
| +2 | K121087 | Contour Next Usb Blood Glucose Monitoring System | Bayer Healthcare | 2012 | — |
| +3 | K150942 | Contour Next USB Blood Glucose Monitoring System | Bayer Healthcare | 2015 | — |
| +4 | K160682 | CONTOUR NEXT ONE Blood Glucose Monitoring System | Ascensia Diabetes Care | 2016 | — |
| +5 | K193407 | Contour® next GEN Blood Glucose Monitoring System | Ascensia Diabetes Care | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (18)
See all 183 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K110894 (Bayer Healthcare, 2012) has gone furthest, with 13 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. 2009, this device’s year, is highlighted.
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 Contour USB Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Contour USB is an over the counter (OTC) device utilized by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The Contour USB Diabetes Care System is indicated for use with capillary, venous and arterial whole blood samples. Capillary samples may be drawn from fingertip, palm and forearm. The…
Read the full statement (149 words)
The Contour USB Blood Glucose Monitoring System is used for the measurement of
glucose in whole blood. The Contour USB is an over the counter (OTC) device utilized
by persons with diabetes and by healthcare professionals in home settings and in
healthcare facilities. The Contour USB Diabetes Care System is indicated for use with
capillary, venous and arterial whole blood samples. Capillary samples may be drawn
from fingertip, palm and forearm. The Contour USB is not intended for the diagnosis of
or screening for diabetes mellitus and is not intended for use on neonates. The frequent
monitoring of blood glucose is an adjunct to the care of persons with diabetes.
GLUCOFACTS® Deluxe Diabetes Management Software is an over-the-counter
software program intended for use by Health Care Professionals and Patients with
Diabetes for viewing and printing reports that display blood sugar readings from Bayer's
CONTOUR® and BREEZE® families of meters.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091820 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091820: Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091820
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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