510(k) · Cleared
ClearedClever Chek TD-3213
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 Mar 7, 2005 as substantially equivalent to K020208 (Bayer Group Diagnostics, 2002) and 1 other predicate after a 151-day review. Its family tree reaches back 2 generations to 2002. 6 later devices descend from it.
- Decided
- Mar 7, 2005
- Review
- 151 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K021239 (2002). 3 ancestors in all, the oldest K020208 (2002). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK021239 Eikon Automatic Digital Blood Pressure Monitor, Model HD-400MEikon Healthcare Device Corp. · 2002
- 1 generation backK040159 Apm Blood Pressure Monitor, Model BP108AAsia Pacific Microsystems, Inc. · 2004
- This deviceK042795 Clever Chek TD-3213Taidoc Technology Corporation · 2005
- 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 · cites it directly · 2 of its ownK052108 Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Sein Electronics Co., Ltd. · 2005
- 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 ownK080853 Duo-Care Blood Glucose and Blood Pressure Monitor SystemGenexel-Sein, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK080636 Duo-Max Blood Pressure & Glucose Monitor HMF-100Hubdic Co., Ltd. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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
- K052108Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Sein Electronics Co., Ltd. · 2005 · cites it directly2descendants
- K092875Echo TD-3227 Dual Blood Pressure/Blood Glucose MeterTaidoc Technology Corporation · 2010 · 2 generations on0descendants
- K080853Duo-Care Blood Glucose and Blood Pressure Monitor SystemGenexel-Sein, Inc. · 2009 · 2 generations on0descendants
- K080636Duo-Max Blood Pressure & Glucose Monitor HMF-100Hubdic Co., Ltd. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021239 | Eikon Automatic Digital Blood Pressure Monitor, Model HD-400M | Eikon Healthcare Device Corp. | 2002 | — |
| −1 | K040159 | Apm Blood Pressure Monitor, Model BP108A | Asia Pacific Microsystems, Inc. | 2004 | — |
| 0 (this device) | K042795 | Clever Chek TD-3213 | Taidoc Technology Corporation | 2005 | — |
| +1 | K062800 | Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/… | Taidoc Technology Corporation | 2007 | — |
| +1 | K052108 | Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100 | Sein Electronics Co., Ltd. | 2005 | — |
| +2 | K092875 | Echo TD-3227 Dual Blood Pressure/Blood Glucose Meter | Taidoc Technology Corporation | 2010 | — |
| +2 | K080853 | Duo-Care Blood Glucose and Blood Pressure Monitor System | Genexel-Sein, Inc. | 2009 | — |
| +2 | K080636 | Duo-Max Blood Pressure & Glucose Monitor HMF-100 | Hubdic Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 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 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 |
|---|---|---|---|
| * | K020208 | Glucometer Elite Diabetes Care System (Modified)Summary page 1…Blood Glucose Test Strips Manufacturer Bayer Diagnostics Asia Pacific Microsystems, Inc. 5 10 (k) Number K020208; K040159 1iI… | 2002 |
| * | K040159 | Apm Blood Pressure Monitor, Model BP108ASummary page 1…Blood Glucose Test Strips Manufacturer Bayer Diagnostics Asia Pacific Microsystems, Inc. 5 10 (k) Number K020208; K040159 1iI Pag… | 2004 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K062800 (Taidoc Technology Corporation, 2007) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K020208.
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 Clever Chek TD-3213 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 glucose in 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 diabetes control program. It is not intended for the diagnosis of or screening…
Read the full statement (134 words)
The Clever Chek TD-3213 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 glucose in 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 diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and 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 pulse rate of an adult individual, over age 16, at home by using a technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 5.25"~7.75".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042795 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042795: Clever Chek TD-3213.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042795
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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