510(k) Report

510(k) · Cleared

Cleared

Achtung Blood Glucose Monitoring System, Model TD-4207

K061181510(k) TraditionalCleared Jul 6, 200670-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 Jul 6, 2006 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.

Decided
Jul 6, 2006
Review
70 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2008: 2 descendants cleared2010: 1 descendant cleared20052010201520202025
  1. This deviceK061181 Achtung Blood Glucose Monitoring System, Model TD-4207Taidoc Technology Corporation · 2006
  2. 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
  3. Descendant · 2 generations on · 0 of its ownK092875 Echo TD-3227 Dual Blood Pressure/Blood Glucose MeterTaidoc Technology Corporation · 2010
  4. Descendant · cites it directly · 0 of its ownK080283 Ideal Life Gluco-Manager GMM 0001 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2008
  5. 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 4 of 4 · 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
  • K080283Ideal Life Gluco-Manager GMM 0001 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2008 · cites it directly0descendants
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K061181Achtung Blood Glucose Monitoring System, Model TD-4207Taidoc Technology Corporation2006—
+1K062800Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/…Taidoc Technology Corporation2007—
+2K092875Echo TD-3227 Dual Blood Pressure/Blood Glucose MeterTaidoc Technology Corporation2010—
+1K080283Ideal Life Gluco-Manager GMM 0001 Blood Glucose Monitoring SystemTaidoc Technology Corporation2008—
+2K080014Clever Chek TD-3250C Blood Glucose Plus Blood Pressure Monitoring SystemTaidoc Technology Corporation2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
201010
FIG. 1 — Lineage of K061181, 2006–2010Source: 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? (4)

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

NumberDeviceApplicantDecidedDescendants
K062800Clever Chek TD-3213/ Clever Chek TD-3215/ DR. T TD-3216/ Clever Chek TD-3217/ Clever…Taidoc Technology Corporation20072
K080283Ideal Life Gluco-Manager GMM 0001 Blood Glucose Monitoring SystemTaidoc Technology Corporation20080

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, K062800 (Taidoc Technology Corporation, 2007) has gone furthest, with 2 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 Blood Glucose Monitoring System 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, 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, and is not intended for use on neonates.

The alternative site testing in the ACHTUNG Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

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/K061181 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061181: Achtung Blood Glucose Monitoring System, Model TD-4207.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061181

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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