510(k) · Cleared
ClearedDiavue Prudential Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocare Corporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Apr 5, 2013 as substantially equivalent to K082482 (Taidoc Technology Corporation, 2009) and 1 other predicate after a 247-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Apr 5, 2013
- Review
- 247 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K082482 (2009). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK082482 Fora TD-4251/U-Right TD-4252/U-Right TD-4254 Blood Glucose…Taidoc Technology Corporation · 2009
- This deviceK122307 Diavue Prudential Blood Glucose Monitoring SystemBiocare Corporation · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082482 | Fora TD-4251/U-Right TD-4252/U-Right TD-4254 Blood Glucose Monitoring System… | Taidoc Technology Corporation | 2009 | — |
| 0 (this device) | K122307 | Diavue Prudential Blood Glucose Monitoring System | Biocare Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K082482 | Fora TD-4251/U-Right TD-4252/U-Right TD-4254 Blood Glucose Monitoring System, Model…Summary page 2…Classification: Class I 3. Predicate lDevice 3.1 Blood Glucose Monitoring System The predicate device is URIGHT TD-4254 Blood Glucose Monitoring System (K082482) marketed by TaiDoc Technology Corporation. 3).2 Controlsolution The predicate device is 'IaiDoc Control Solution and F… | 2009 |
| * | K093724 | Fora Control Solution, Taidoc Control SolutionSummary page 2…ng System (K082482) marketed by TaiDoc Technology Corporation. 3).2 Controlsolution The predicate device is 'IaiDoc Control Solution and FORA Control Solution (K093724) marketed by Tai[)oc Technology Corporation. 4. Device IDescription The DIAVUE Prudential Blood Glucose Monitoring Syste… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K082482.
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. 2013, 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 DIAVUE Prudential Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples (from finger). This system is intended to be used by a single person and should not be shared. It should not be used for the diagnosis of or…
Read the full statement (200 words)
The DIAVUE Prudential Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples (from finger). This system is intended to be used by a single person and should not be shared. It should not be used for the diagnosis of or screening for diabetes, or testing on neonates.
The DIAVUE Blood Glucose Test Strips are to be used with the DIAVUE Prudential Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip. It is for use outside of body (in vitro diagnostic use). It is intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
The DIAVUE Control Solutions are used with the DIAVUE Prudential Blood Glucose Meter and DIAVUE Blood Glucose Test Strips to indicate appropriate user technique and to indicate that the test strip and meter are functioning properly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122307: Diavue Prudential Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122307
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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