510(k) · Cleared
ClearedAscensia Dex 2 Diabetes Care System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Nov 20, 2002 as substantially equivalent to K020210 (Bayer Group Diagnostics, 2002) after a 26-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Nov 20, 2002
- Review
- 26 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020210 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK020210 Glucometer Dex Blood Glucose System (Modified)Bayer Group Diagnostics · 2002
- This deviceK023584 Ascensia Dex 2 Diabetes Care SystemBayer Corp. · 2002
- Descendant · cites it directly · 1 of its ownK082395 Glucose Meter-Check Control Solution for Bayer Ascensia Blood…Bionostics, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK123966 Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020210 | Glucometer Dex Blood Glucose System (Modified) | Bayer Group Diagnostics | 2002 | — |
| 0 (this device) | K023584 | Ascensia Dex 2 Diabetes Care System | Bayer Corp. | 2002 | — |
| +1 | K082395 | Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter… | Bionostics, Inc. | 2008 | — |
| +2 | K123966 | Glucose Meter-Check Solution for Bayer | Bionostics, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K020210 | Glucometer Dex Blood Glucose System (Modified) | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082395 | Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002 | 2008 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K082395 (Bionostics, Inc., 2008) has gone furthest, with 1 descendant 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 ASCENSIATMDEX82 Blood Glucose Meter is used with ASCENSIATMAUTODISCTMBlood Glucose Test Strips GLUCOMETER@ DEX8 Test Sensor and Controls for the measurement of glucose in whole blood. The ASCENSIATMDEX82 Diabetes Care 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 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/K023584 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023584: Ascensia Dex 2 Diabetes Care System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023584
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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