510(k) Report

510(k) · Cleared

Cleared

Clever Chek Health Care System Software, Version 1.0

K070941510(k) TraditionalCleared Jun 21, 200778-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 Jun 21, 2007 as substantially equivalent to K001907 (Roche Diagnostics Corp., 2000) after a 78-day review. Its family tree reaches back 1 generation to 2000. 8 later devices descend from it.

Decided
Jun 21, 2007
Review
78 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001907 (2000). 8 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2011: 4 descendants cleared2013: 2 descendants cleared2012: 1 descendant cleared2014: 1 descendant clearedK001907 · Camit Diabetes Management Software · Roche Diagnostics Corp. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K001907 · Camit Diabetes Management Software · Roche Diagnostics Corp. · 20000
  1. Root · 1 generation backK001907 Camit Diabetes Management SoftwareRoche Diagnostics Corp. · 2000
  2. This deviceK070941 Clever Chek Health Care System Software, Version 1.0Taidoc Technology Corporation · 2007
  3. Descendant · cites it directly · 3 of its ownK110948 Health Care System SoftwareTaidoc Technology Corporation · 2011
  4. Descendant · 2 generations on · 2 of its ownK113264 Electro Sensor Complex Software (ES Complex Software)Ld Technology, LLC · 2012
  5. Descendant · cites it directly · 1 of its ownK102678 Andon Health Care Management System Software, AG-608 Single & AG-608…Andon Medical Co., Ltd. · 2011
  6. Descendant · 3 generations on · 0 of its ownK140412 ANS1 SoftwareLd Technology, LLC · 2014
  7. Descendant · cites it directly · 0 of its ownK130621 Broadmaster Healthcare SystemBroadmaster Biotech Corporation · 2013

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2011: 42012: 12013: 22014: 1
2011high 4 (2011) · low 0 (2015)2026

Most influential descendants

Showing 5 of 8 · See all
  • K110948Health Care System SoftwareTaidoc Technology Corporation · 2011 · cites it directly3descendants
  • K113264Electro Sensor Complex Software (ES Complex Software)Ld Technology, LLC · 2012 · 2 generations on2descendants
  • K102678Andon Health Care Management System Software, AG-608 Single & AG-608 Multi Blood Glucose…Andon Medical Co., Ltd. · 2011 · cites it directly1descendant
  • K140412ANS1 SoftwareLd Technology, LLC · 2014 · 3 generations on0descendants
  • K130621Broadmaster Healthcare SystemBroadmaster Biotech Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001907Camit Diabetes Management SoftwareRoche Diagnostics Corp.2000—
0 (this device)K070941Clever Chek Health Care System Software, Version 1.0Taidoc Technology Corporation2007—
+1K110948Health Care System SoftwareTaidoc Technology Corporation2011—
+2K113264Electro Sensor Complex Software (ES Complex Software)Ld Technology, LLC2012—
+1K102678Andon Health Care Management System Software, AG-608 Single & AG-608 Multi…Andon Medical Co., Ltd.2011—
+3K140412ANS1 SoftwareLd Technology, LLC2014—
+1K130621Broadmaster Healthcare SystemBroadmaster Biotech Corporation2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201140
201210
201320
201410
FIG. 1 — Lineage of K070941, 2000–2014Source: 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 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
*K001907Camit Diabetes Management Software
Summary page 1
…amit Diabetes Management Software Common/Usual Name: Data management software Submitter Roche Diagnostics Corporation 510 (k) Number K001907 Page 2-of-2 4. Device Description The Cle…
Roche Diagnostics Corp.2000—

Also cleared against K001907: 2 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K110948Health Care System SoftwareTaidoc Technology Corporation20113
K102678Andon Health Care Management System Software, AG-608 Single & AG-608 Multi Blood Glucose…Andon Medical Co., Ltd.20111
K130621Broadmaster Healthcare SystemBroadmaster Biotech Corporation20130
K110770HealthtrackerWistron Corporation20110

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?

  • Its one ancestor has no recall.
  • Of its descendants, K110948 (Taidoc Technology Corporation, 2011) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K001907.

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 Health Care System Software is an optional software accessory for use with the following models with data management capabilities: a) Clever Chek blood glucose meters, b) Clever Chek blood glucose plus blood pressure monitors, and c) Clever blood pressure monitors. When use with one of these meters, Clever Chek Health Care System Software transfers data from the device's memory into a computer for enhanced data management.

The Clever Chek Health Care System Software is intended for use in home and clinical settings as an aid for users and their health care professionals to review, analyze and evaluate the historical test results to support health management effectively.

Indications for use as stated in the FDA summary.

Also cleared against K001907

2 other devices cite the same predicate.

  • K080227Accu-Chek 360 Diabetes Management SystemRoche Diagnostics Corp. · 2008
  • K022545Glucobalance Data Management Software, Model 555020Hypoguard USA, Inc. · 2002

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/K070941 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070941: Clever Chek Health Care System Software, Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070941

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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