510(k) Report

510(k) · Cleared

Cleared

Clever Chek TD-4209 Blood Glucose Monitoring System, Model TD-4209, TD-4222, TD-4225

K071493510(k) TraditionalCleared Oct 26, 2007149-day reviewClass II21 CFR 862.1345

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Taidoc Technology Corporation · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Oct 26, 2007 as substantially equivalent to K060620 (Roche Diagnostics Corp., 2006) after a 149-day review. Its family tree reaches back 3 generations to 2001.

Decided
Oct 26, 2007
Review
149 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K010362 (2001). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestorK010362 · Accu-Chek Comfort Curve Test Strip · Roche Diagnostics Corp. · 2001 · recalledK043474 · Accu-Chek Aviva System · Roche Diagnostics Corp. · 2005 · recalledK060620 · Accu-Chek Aviva Test Strips · Roche Diagnostics Corp. · 2006 · recalled20002002200420062008
Other ancestors, by generation 3 generations back: 1 other ancestor K060620 · Accu-Chek Aviva Test Strips · Roche Diagnostics Corp. · 2006 · recalledK043474 · Accu-Chek Aviva System · Roche Diagnostics Corp. · 2005 · recalledK010362 · Accu-Chek Comfort Curve Test Strip · Roche Diagnostics Corp. · 2001 · recalled0
  1. Root · 3 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
  2. 2 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
  3. 1 generation backK060620 Accu-Chek Aviva Test StripsRoche Diagnostics Corp. · 2006 · Recalled
  4. This deviceK071493 Clever Chek TD-4209 Blood Glucose Monitoring System, Model TD-4209…Taidoc Technology Corporation · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K010362Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp.20016
−2K043474Accu-Chek Aviva SystemRoche Diagnostics Corp.200510
−1K060620Accu-Chek Aviva Test StripsRoche Diagnostics Corp.20061
0 (this device)K071493Clever Chek TD-4209 Blood Glucose Monitoring System, Model TD-4209, TD-4222…Taidoc Technology Corporation2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K071493, 2001–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K060620Accu-Chek Aviva Test Strips
Summary page 1
…Name: ACCU-CHEK Aviva test strips Common/Usual Name: Blood Glucose test system Manufacturer Roche Diagnostics 510 (k) Number K060620 Page 2-of-3 4. Device Description Clever Ch…
Roche Diagnostics Corp.20061

Also cleared against K060620: 1 other device →

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 6 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
  • 3 of the 4 ancestors have a recall of any class.
  • 1 other device also cites its predicate K060620.

How does its category compare?

All NBW devices

NBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NBW

2in 2025

2007: 292008: 372009: 382010: 312011: 302012: 302013: 472014: 242015: 322016: 202017: 252018: 192019: 102020: 72021: 72022: 122023: 52024: 72025: 22026 (partial year): 5
2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007: 85 days median2008: 128 days median2009: 140 days median2010: 132 days median2011: 328 days median2012: 230 days median2013: 167 days median2014: 202 days median2015: 237 days median2016: 233 days median2017: 244 days median2018: 168 days median2019: 127 days median2020: 121 days median2021: 465 days median2022: 410 days median2023: 193 days median2024: 243 days median2026 (partial year): 190 days median
2007high 465 (2021) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NBW

1in 2025

2007: 92008: 22009: 52010: 112011: 12012: 12013: 5, 2 Class I2014: 12016: 12019: 142025: 1
2007high 14 (2019) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NBW

4,745in 2025

2007: 7,9912008: 7,7042009: 10,9632010: 11,6312011: 22,9092012: 23,4492013: 35,4082014: 38,5242015: 62,1112016: 76,6212017: 37,5382018: 16,9112019: 14,4722020: 10,7032021: 9,1982022: 8,1032023: 7,2562024: 6,2202025: 4,745
2007high 76,621 (2016) · low 4,745 (2025)2025

MAUDE reports naming product code NBW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007298597,991
20083712827,704
200938140510,963
2010311321111,631
201130328122,909
201230230123,449
2013471675 (2)35,408
201424202138,524
201532237062,111
201620233176,621
201725244037,538
201819168016,911
2019101271414,472
20207121010,703
2021746509,198
20221241008,103
2023519307,256
2024724306,220
20252—14,745
202651900—

What is it indicated for?

The Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 Blood glucose monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the foliowing 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…

Read the full statement (149 words)

The Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 Blood glucose monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the foliowing 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 alternative site testing in the Clever Chek TD-4209/ Clever Chek TD-4222/ Clever Chek TD-4225 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.

Professionals may use the Clever Chek TD-4209/ Clever Chek TD-4222 Blood/ Clever Chek TD-4225 glucose monitoring system to test neonatal blood from the heel, but may not be used in screening for neonatal hypoglycemia.

Indications for use as stated in the FDA summary.

Also cleared against K060620

1 other device cites the same predicate.

  • K101299Accu-Chek Aviva Plus Blood Glucose Monitoring SystemRoche Diagnostics · 2011

More from Taidoc Technology Corporation

123 FDA decisions under this applicant name. See the company

  • K221349XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2024
  • K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022
  • K200946Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)Taidoc Technology Corporation · 2022
  • K190579TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2019
  • K182934FORA P100 Blood Pressure Monitoring SystemTaidoc Technology Corporation · 2019

Recent decisions in NBW

The NBW category page

  • K261293EASYMAX Voice Blood Glucose Monitoring SystemEPS Bio Technology Corp. · 2026
  • K260687VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual…Vivachek Biotech (Hangzhou) Co., Ltd. · 2026
  • K260689CVS Advanced PLUS Blood Glucose Monitoring SystemI-Sens, Inc. · 2026
  • K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System…Ascensia Diabetes Care · 2026
  • K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 2026

https://510kreport.com/device/K071493 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071493: Clever Chek TD-4209 Blood Glucose Monitoring System, Model TD-4209, TD-4222, TD-4225.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071493

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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