510(k) · Cleared
ClearedClever Choice Auto-Code Pro Blood Glucose Monitoring System Model TD-4267
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · CGA Glucose Oxidase, Glucose
Cleared on Apr 1, 2010 as substantially equivalent to K090187 (Taidoc Technology Corporation, 2009) after a 140-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Apr 1, 2010
- Review
- 140 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070472 (2007). No later device cites it as a predicate yet.
- Root · 2 generations backK070472 Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230…Taidoc Technology Corporation · 2007
- 1 generation backK090187 Fora G30 Blood Glucose Monitoring System, Model TD-4241Taidoc Technology Corporation · 2009
- This deviceK093506 Clever Choice Auto-Code Pro Blood Glucose Monitoring System Model…Taidoc Technology Corporation · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070472 | Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230, Surechek Blood… | Taidoc Technology Corporation | 2007 | — |
| −1 | K090187 | Fora G30 Blood Glucose Monitoring System, Model TD-4241 | Taidoc Technology Corporation | 2009 | — |
| 0 (this device) | K093506 | Clever Choice Auto-Code Pro Blood Glucose Monitoring System Model TD-4267 | Taidoc Technology Corporation | 2010 | — |
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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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 |
|---|---|---|---|
| * | K090187 | Fora G30 Blood Glucose Monitoring System, Model TD-4241Summary page 1…ring System Common/Usual Name: Blood Glucose Test System Manufacturer TaiDoc Technology Corporation 510 (k) Number K090187 4. Device Description The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System is designed to quantitatively measure the… | 2009 |
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?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- 7 other devices also cite its predicate K090187.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not…
Read the full statement (113 words)
The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System is intended
for use in the quantitative measurement of glucose in fresh capillary whole blood
samples from the finger and the following alternative sites: the palm, the forearm, the
upper-arm, the calf and the thigh. It is intended for use by healthcare professionals
and people with diabetes mellitus at home as an aid in monitoring the effectiveness of
diabetes control program. It is not intended for the diagnosis of or screening for
diabetes mellitus.
The CLEVER CHOICE Auto-Code Pro Blood Glucose Monitoring System cannot be
used on neonates.
The alternative site testing in above systems can be used only during steady-state
blood glucose conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093506: Clever Choice Auto-Code Pro Blood Glucose Monitoring System Model TD-4267.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093506
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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