510(k) · Cleared
ClearedProdigy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Devices, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jul 6, 2006 as substantially equivalent to K042005 (Taidoc Technology Corporation, 2004) after a 195-day review. Its family tree reaches back 1 generation to 2004. 3 later devices descend from it.
- Decided
- Jul 6, 2006
- Review
- 195 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042005 (2004). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK042005 Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Taidoc Technology Corporation · 2004
- This deviceK053593 ProdigyDiagnostic Devices, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK113077 Bioland G-423 Glood Glucose Monitoring SystemTaidoc Technology Corporation · 2012
- Descendant · 2 generations on · 1 of its ownK191657 Bioland Blood Glucose Monitoring SystemBioland Technology, Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK202739 Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2…Bioland Technology, Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K113077Bioland G-423 Glood Glucose Monitoring SystemTaidoc Technology Corporation · 2012 · cites it directly2descendants
- K191657Bioland Blood Glucose Monitoring SystemBioland Technology, Ltd. · 2020 · 2 generations on1descendant
- K202739Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose…Bioland Technology, Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042005 | Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222 | Taidoc Technology Corporation | 2004 | — |
| 0 (this device) | K053593 | Prodigy | Diagnostic Devices, Inc. | 2006 | — |
| +1 | K113077 | Bioland G-423 Glood Glucose Monitoring System | Taidoc Technology Corporation | 2012 | — |
| +2 | K191657 | Bioland Blood Glucose Monitoring System | Bioland Technology, Ltd. | 2020 | — |
| +3 | K202739 | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood… | Bioland Technology, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K042005 | Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Summary page 1…ystem and Quality Control Material Safety and Effective Information Predicate Device: Claim of Substantial Equivalence (SE) is made to TaiDoc Technology Corporation. K042005, Achtung TD-4207/ Clever Chek TD-4209/ Clever Chek TD-4222 Glucose Test Systems.… | 2004 |
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 |
|---|---|---|---|
| K113077 | Bioland G-423 Glood Glucose Monitoring System | 2012 | 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?
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 Prodigy Blood Glucose Test System is intended to be used for the quantitative measurement of glucose in capillary whole blood from the fingertip. It is intended for use by people with diabetes mellitus at home (Over -the-Counter) as an aid in monitoring the effectiveness of diabetes control program. The Prodigy blood glucose test system can also be used at clinical sites by nurses or professional people to test patient's glucose level in whole blood. It is not intended for the diagnosis of or screening for diabetes mellitus, and not intended for use on neonates.
The Prodigy meter is to be used with the Prodigy Blood Glucose Test Strip, and the Prodigy Glucose Control Solutions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053593 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053593: Prodigy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053593
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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