510(k) Report

510(k) · Cleared

Cleared

Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222

K042005510(k) SpecialCleared Aug 27, 200432-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 Aug 27, 2004 after a 32-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 26 later devices descend from it.

Decided
Aug 27, 2004
Review
32 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
0

26 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared2012: 1 descendant cleared2016: 2 descendants cleared2008: 2 descendants cleared2007: 1 descendant cleared2010: 5 descendants cleared2013: 4 descendants cleared2009: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2014: 2 descendants cleared2015: 2 descendants cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK042005 Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Taidoc Technology Corporation · 2004
  2. Descendant · cites it directly · 17 of its ownK060467 Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc. · 2006
  3. Descendant · 2 generations on · 14 of its ownK073118 Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc. · 2008
  4. Descendant · 3 generations on · 6 of its ownK091815 Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp. · 2009
  5. Descendant · 3 generations on · 3 of its ownK122338 Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC · 2013
  6. Descendant · cites it directly · 3 of its ownK053593 ProdigyDiagnostic Devices, Inc. · 2006

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2006: 32007: 12008: 22009: 12010: 52012: 12013: 42014: 22015: 22016: 22017: 12020: 12022: 1
2006high 5 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 26 · See all
  • K060467Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc. · 2006 · cites it directly17descendants
  • K073118Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc. · 2008 · 2 generations on14descendants
  • K091815Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp. · 2009 · 3 generations on6descendants
  • K122338Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC · 2013 · 3 generations on3descendants
  • K053593ProdigyDiagnostic Devices, Inc. · 2006 · cites it directly3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042005Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Taidoc Technology Corporation2004—
+1K060467Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc.2006—
+2K073118Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc.2008—
+3K091815Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp.2009—
+3K122338Preferred Blood Glucose Monitoring SystemProdigy Diabetes Care, LLC2013—
+1K053593ProdigyDiagnostic Devices, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200630
200710
200820
200910
201050
201210
201340
201420
201520
201620
201710
202010
202210
FIG. 1 — Lineage of K042005, 2004–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (26)

See all 26

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060467Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc.200617
K053593ProdigyDiagnostic Devices, Inc.20063
K061073Clever Check TD-3250 Blood Glucose and Blood Pressure Measurement System, Model TD-3250Taidoc Technology Corporation20063

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?

  • Of its descendants, K060467 (Diagnostic Devices, Inc., 2006) has gone furthest, with 17 descendants of its own.

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.

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 Achtung TD-4207 / Clever Chek TD-4209 / Clever Chek TD-4222 Glucose Test Systems are intended for use in the quantitative measurement of glucose in whole blood taken from the finger. They are intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. They are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

Indications for use as stated in the FDA 510(k) statement.

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/K042005 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042005: Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042005

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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