510(k) Report

510(k) · Cleared

Cleared

Fora GD20 Blood Glucose Monitoring System, U-Rught TD-4252D Blood Glucose Monitoring System

K101631510(k) TraditionalCleared Sep 2, 2011449-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 Sep 2, 2011 after a 449-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Sep 2, 2011
Review
449 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2013: 1 descendant cleared2012: 1 descendant cleared2010201520202025
  1. This deviceK101631 Fora GD20 Blood Glucose Monitoring System, U-Rught TD-4252D Blood…Taidoc Technology Corporation · 2011
  2. Descendant · cites it directly · 0 of its ownK124040 Foracare GD20 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2013
  3. Descendant · cites it directly · 0 of its ownK121224 Genesis Health Technologies Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K124040Foracare GD20 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2013 · cites it directly0descendants
  • K121224Genesis Health Technologies Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K101631Fora GD20 Blood Glucose Monitoring System, U-Rught TD-4252D Blood Glucose…Taidoc Technology Corporation2011—
+1K124040Foracare GD20 Blood Glucose Monitoring SystemTaidoc Technology Corporation2013—
+1K121224Genesis Health Technologies Blood Glucose Monitoring SystemTaidoc Technology Corporation2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
FIG. 1 — Lineage of K101631, 2011–2013Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K124040Foracare GD20 Blood Glucose Monitoring SystemTaidoc Technology Corporation20130
K121224Genesis Health Technologies Blood Glucose Monitoring SystemTaidoc 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?

  • Of its descendants, K124040 (Taidoc Technology Corporation, 2013) has gone furthest, with 0 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. 2011, 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—

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/K101631 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101631: Fora GD20 Blood Glucose Monitoring System, U-Rught TD-4252D Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101631

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026