510(k) · Cleared
ClearedGlucometer Dex Blood Glucose System (Modified)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Group Diagnostics · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Apr 30, 2002 after a 98-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Apr 30, 2002
- Review
- 98 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK020210 Glucometer Dex Blood Glucose System (Modified)Bayer Group Diagnostics · 2002
- Descendant · cites it directly · 2 of its ownK023584 Ascensia Dex 2 Diabetes Care SystemBayer Corp. · 2002
- 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
Most influential descendants
Showing 3 of 3 · See all- K023584Ascensia Dex 2 Diabetes Care SystemBayer Corp. · 2002 · cites it directly2descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020210 | Glucometer Dex Blood Glucose System (Modified) | Bayer Group Diagnostics | 2002 | — |
| +1 | K023584 | Ascensia Dex 2 Diabetes Care System | Bayer Corp. | 2002 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | — | GLUCOMETER® DEX® Blood Glucose Meter Named without a submission number | |
| * | — | GLUCOMETER® DEX® Test Sensors Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023584 | Ascensia Dex 2 Diabetes Care System | 2002 | 2 |
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, K023584 (Bayer Corp., 2002) has gone furthest, with 2 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 GLUCOMETER® DEX® 2 Blood Glucose Meter and the GLUCOMETER® DEX® Test Sensors are used to measure the glucose levels in whole blood from specimens taken from the fingers or an alternate puncture sites within certain conditions. The GLUCOMETER® DEX® Diabetes Care System is an over-the-counter (OTC) device used by persons with diabetes in a home setting and by healthcare professionals in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020210: Glucometer Dex Blood Glucose System (Modified).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020210
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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