510(k) Report

510(k) · Cleared

Cleared

TD-4277 Blood Glucose Monitoring System, Model 4277

K100322510(k) TraditionalCleared Jun 28, 2010144-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 28, 2010 as substantially equivalent to K082169 (Taidoc Technology Corporation, 2008) and 1 other predicate after a 144-day review. Its family tree reaches back 3 generations to 2003. 6 later devices descend from it.

Decided
Jun 28, 2010
Review
144 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K031755 (2003). 5 ancestors in all. 6 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2007: 1 other ancestor2019: 1 descendant cleared2018: 2 descendants cleared2012: 2 descendants cleared2024: 1 descendant clearedK031755 · Accu-Chek Compact Test Strip · Roche Diagnostics Corp. · 2003K040796 · Accu-Chek GO System · Roche Diagnostics Corp. · 2004 · recalledK082169 · Pro Glucose Test Strip · Taidoc Technology Corporation · 2008200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 1 descendant K082169 · Pro Glucose Test Strip · Taidoc Technology Corporation · 2008K040796 · Accu-Chek GO System · Roche Diagnostics Corp. · 2004 · recalledK031755 · Accu-Chek Compact Test Strip · Roche Diagnostics Corp. · 20030
  1. Root · 3 generations backK031755 Accu-Chek Compact Test StripRoche Diagnostics Corp. · 2003
  2. 2 generations backK040796 Accu-Chek GO SystemRoche Diagnostics Corp. · 2004 · Recalled
  3. 1 generation backK082169 Pro Glucose Test StripTaidoc Technology Corporation · 2008
  4. This deviceK100322 TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation · 2010
  5. Descendant · cites it directly · 1 of its ownK190579 TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2019
  6. Descendant · 2 generations on · 0 of its ownK222126 VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart…Vivachek Biotech (Hangzhou) Co., Ltd. · 2024
  7. Descendant · cites it directly · 0 of its ownK181588 POPS! one Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2018
  8. Descendant · cites it directly · 0 of its ownK173511 ActiveCare TD-4121 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2018
  9. Descendant · cites it directly · 0 of its ownK113768 U-Right TD-4280 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2012: 22018: 22019: 12024: 1
2012high 2 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 6 · See all
  • K190579TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2019 · cites it directly1descendant
  • K222126VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose…Vivachek Biotech (Hangzhou) Co., Ltd. · 2024 · 2 generations on0descendants
  • K181588POPS! one Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2018 · cites it directly0descendants
  • K173511ActiveCare TD-4121 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2018 · cites it directly0descendants
  • K113768U-Right TD-4280 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K031755Accu-Chek Compact Test StripRoche Diagnostics Corp.2003—
−2K040796Accu-Chek GO SystemRoche Diagnostics Corp.20042
−1K082169Pro Glucose Test StripTaidoc Technology Corporation2008—
0 (this device)K100322TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation2010—
+1K190579TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation2019—
+2K222126VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood…Vivachek Biotech (Hangzhou) Co., Ltd.2024—
+1K181588POPS! one Blood Glucose Monitoring SystemTaidoc Technology Corporation2018—
+1K173511ActiveCare TD-4121 Blood Glucose Monitoring SystemTaidoc Technology Corporation2018—
+1K113768U-Right TD-4280 Blood Glucose Monitoring SystemTaidoc Technology Corporation2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200710
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201220
201820
201910
202410
FIG. 1 — Lineage of K100322, 2003–2024Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K082169Pro Glucose Test Strip
Summary page 2
…r as a system to produce accurate blood glucose test results. 5. Substantial Equivalence Information: A. Predicate device name: TaiDoc Pro I Glucose Test Strip, k082169 FORA 030 blo od glucose monitoring system, k0901 87 B. Comparison with predicate:I The TD-4277 BLOOD GLUCOSE MONITORI…
Taidoc Technology Corporation2008—
*K090187Fora G30 Blood Glucose Monitoring System, Model TD-4241
Summary page 2
…sults. 5. Substantial Equivalence Information: A. Predicate device name: TaiDoc Pro I Glucose Test Strip, k082169 FORA 030 blo od glucose monitoring system, k0901 87 B. Comparison with predicate:I The TD-4277 BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4277 has the equivalent technolog…
Taidoc Technology Corporation2009—

Also cleared against K082169: 2 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K190579TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation20191
K181588POPS! one Blood Glucose Monitoring SystemTaidoc Technology Corporation20180
K173511ActiveCare TD-4121 Blood Glucose Monitoring SystemTaidoc Technology Corporation20180
K113768U-Right TD-4280 Blood Glucose Monitoring SystemTaidoc Technology Corporation20120
K111890Fora Diamond Prima Blood Glucose Monitoring System, Fora Diamond Mini Blood Glucose…Taidoc Technology Corporation20120

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 7 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K190579 (Taidoc Technology Corporation, 2019) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K082169.

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. 2010, 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?

TD-4277 Blood Glucose Monitoring System, Model TD-4277 is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. 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.

Professionals may use the test strips to test capillary and venous blood samples, but lay user may not test venous blood samples.

Indications for use as stated in the FDA summary.

Also cleared against K082169

2 other devices cite the same predicate.

  • K092688Fora Poct S10/TD-4258 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2011
  • K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010

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/K100322 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100322: TD-4277 Blood Glucose Monitoring System, Model 4277.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100322

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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