510(k) · Cleared
ClearedClever Check TD-3250 Blood Glucose and Blood Pressure Measurement System, Model TD-3250
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Jun 2, 2006 as substantially equivalent to K042005 (Taidoc Technology Corporation, 2004) and 1 other predicate after a 46-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Jun 2, 2006
- Review
- 46 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K012636 (2001). 2 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK012636 Bptru Automated Non-Invasive Blood Pressure Monitor, Model BPM-100Vsm Technology, Inc. · 2001
- This deviceK061073 Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement…Taidoc Technology Corporation · 2006
- Descendant · cites it directly · 2 of its ownK062800 Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek…Taidoc Technology Corporation · 2007
- Descendant · 2 generations on · 0 of its ownK092875 Echo TD-3227 Dual Blood Pressure/Blood Glucose MeterTaidoc Technology Corporation · 2010
- Descendant · 2 generations on · 0 of its ownK080014 Clever Chek TD-3250C Blood Glucose Plus Blood Pressure Monitoring…Taidoc Technology Corporation · 2008
Most influential descendants
Showing 3 of 3 · See all- K062800Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/ Clever…Taidoc Technology Corporation · 2007 · cites it directly2descendants
- K092875Echo TD-3227 Dual Blood Pressure/Blood Glucose MeterTaidoc Technology Corporation · 2010 · 2 generations on0descendants
- K080014Clever Chek TD-3250C Blood Glucose Plus Blood Pressure Monitoring SystemTaidoc Technology Corporation · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012636 | Bptru Automated Non-Invasive Blood Pressure Monitor, Model BPM-100 | Vsm Technology, Inc. | 2001 | — |
| 0 (this device) | K061073 | Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement System… | Taidoc Technology Corporation | 2006 | — |
| +1 | K062800 | Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/… | Taidoc Technology Corporation | 2007 | — |
| +2 | K092875 | Echo TD-3227 Dual Blood Pressure/Blood Glucose Meter | Taidoc Technology Corporation | 2010 | — |
| +2 | K080014 | Clever Chek TD-3250C Blood Glucose Plus Blood Pressure Monitoring System | Taidoc Technology Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K042005 | Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Summary page 1…Blood Glucose Test Strips Manufacturer TaiDoc Technology Corporation. VSM Med[Tech Ltd. 5 10 (k) Number K042005; K0 12636 iii… | 2004 |
| * | K012636 | Bptru Automated Non-Invasive Blood Pressure Monitor, Model BPM-100Summary page 1…lood Glucose Test Strips Manufacturer TaiDoc Technology Corporation. VSM Med[Tech Ltd. 5 10 (k) Number K042005; K0 12636 iii Pa… | 2001 |
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 |
|---|---|---|---|
| K062800 | Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/ Clever… | 2007 | 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 DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The Clever Chek TD-3250 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary whole blood from the fingertip. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for…
Read the full statement (139 words)
The Clever Chek TD-3250 Blood Glucose and Blood Pressure Measurement System is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary whole blood from the fingertip. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pluse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4 inches to - 13.8 inches.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061073: Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement System, Model TD-3250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061073
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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