510(k) · Cleared
ClearedAdvocate Redi-Cod Duo Blood Glucose Plus Blood Pressure Monitoring System, Model TD-3223
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Feb 25, 2010 as substantially equivalent to K070641 (Taidoc Technology Corporation, 2007) after a 98-day review. Its family tree reaches back 1 generation to 2007.
- Decided
- Feb 25, 2010
- Review
- 98 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070641 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK070641 Advocate Duo Blood Glucose Plus Blood Pressure Monitoring System…Taidoc Technology Corporation · 2007
- This deviceK093592 Advocate Redi-Cod Duo Blood Glucose Plus Blood Pressure Monitoring…Taidoc Technology Corporation · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070641 | Advocate Duo Blood Glucose Plus Blood Pressure Monitoring System, Model TD-3223 | Taidoc Technology Corporation | 2007 | — |
| 0 (this device) | K093592 | Advocate Redi-Cod Duo Blood Glucose Plus Blood Pressure Monitoring System… | 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 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 |
|---|---|---|---|
| * | K070641 | Advocate Duo Blood Glucose Plus Blood Pressure Monitoring System, Model TD-3223Summary page 2…Equivalence Information: A. Predicate device name: ADVOCATE DUO blood glucose plus blood pressure monitoring system B. Predicate K number: K070641 C. Comparison with predicate: The modified ADVOCATE Rcdi-Code Duo Blood Glucose plus Blood Pressure… | 2007 |
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?
- Its one ancestor has no recall.
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. 2010, 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?
ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, model no. TD-3223E is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, forearm, upper-arm, calf and 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.…
Read the full statement (167 words)
ADVOCATE Redi-Code Duo Blood Glucose plus Blood Pressure Monitoring System, model no. TD-3223E is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and from the following alternative sites: the palm, forearm, upper-arm, calf and 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. The alternative site testing in the system can be used only during steady-state blood glucose conditions.
The system is also intended to measure non-invasively the systolic and diastolic blood pressure and pulse rate. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25' to 7.75".
The device is not to be used for the diagnosis or screening of diabetes, hypertension or for testing on neonates.
This monitor contains some speaking functions but is not intended for use by the visually impaired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093592: Advocate Redi-Cod Duo Blood Glucose Plus Blood Pressure Monitoring System, Model TD-3223.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093592
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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