510(k) Report

510(k) · Cleared

Cleared

Fora G30 Blood Glucose Monitoring System, Model TD-4241

K090187510(k) TraditionalCleared May 12, 2009106-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 May 12, 2009 as substantially equivalent to K070472 (Taidoc Technology Corporation, 2007) after a 106-day review. Its family tree reaches back 1 generation to 2007. 26 later devices descend from it.

Decided
May 12, 2009
Review
106 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K070472 (2007). 26 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2010: 8 descendants cleared2011: 4 descendants cleared2019: 1 descendant cleared2018: 4 descendants cleared2012: 4 descendants cleared2013: 1 descendant cleared2017: 1 descendant cleared2015: 2 descendants cleared2024: 1 descendant clearedK070472 · Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230, Surechek Blood Glucose Monitoring System, SMS-4230 · Taidoc Technology Corporation · 200720052010201520202025
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 8 descendants3 generations forward: 7 descendants4 generations forward: 3 descendants K070472 · Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230, Surechek Blood Glucose Monitoring System, SMS-4230 · Taidoc Technology Corporation · 20070
  1. Root · 1 generation backK070472 Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230…Taidoc Technology Corporation · 2007
  2. This deviceK090187 Fora G30 Blood Glucose Monitoring System, Model TD-4241Taidoc Technology Corporation · 2009
  3. Descendant · cites it directly · 11 of its ownK094005 Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora…Taidoc Technology Corporation · 2010
  4. Descendant · 2 generations on · 6 of its ownK101509 U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272…Taidoc Technology Corporation · 2011
  5. Descendant · cites it directly · 6 of its ownK100322 TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation · 2010
  6. Descendant · 2 generations on · 3 of its ownK101635 TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood…Taidoc Technology Corporation · 2011
  7. Descendant · 2 generations on · 1 of its ownK190579 TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2019

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2010: 82011: 42012: 42013: 12015: 22017: 12018: 42019: 12024: 1
2010high 8 (2010) · low 0 (2014)2026

Most influential descendants

Showing 5 of 26 · See all
  • K094005Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora G31B/TD-4256B Blood Glucose…Taidoc Technology Corporation · 2010 · cites it directly11descendants
  • K101509U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 Blood Glucose…Taidoc Technology Corporation · 2011 · 2 generations on6descendants
  • K100322TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation · 2010 · cites it directly6descendants
  • K101635TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2011 · 2 generations on3descendants
  • K190579TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2019 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K070472Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230, Surechek Blood…Taidoc Technology Corporation2007—
0 (this device)K090187Fora G30 Blood Glucose Monitoring System, Model TD-4241Taidoc Technology Corporation2009—
+1K094005Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora G31B/TD-4256B…Taidoc Technology Corporation2010—
+2K101509U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 Blood…Taidoc Technology Corporation2011—
+1K100322TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation2010—
+2K101635TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose…Taidoc Technology Corporation2011—
+2K190579TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201080
201140
201240
201310
201520
201710
201840
201910
202410
FIG. 1 — Lineage of K090187, 2007–2024Source: 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), 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
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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
*K070472Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230, Surechek Blood Glucose…
Summary page 1
…Blood Glucose Meter Blood Glucose Test Strips Manufacturer TaiDoc Technology Corporation 510 (k) Number K070472 Page 2-of-2 4. Device Description FORA G3…
Taidoc Technology Corporation2007—

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K094005Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora G31B/TD-4256B Blood Glucose…Taidoc Technology Corporation201011
K100322TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation20106
K093635Models Fora V30 and TD-4242 Blood Glucose Monitoring SystemsTaidoc Technology Corporation20101
K100732Fora G30A Blood Glucose Monitoring System, Model TD-4241Taidoc Technology Corporation20100
K093506Clever Choice Auto-Code Pro Blood Glucose Monitoring System Model TD-4267Taidoc Technology Corporation20100
K093941Clever Choice Mini Blood Glucose Monitoring System Model TD-4265Taidoc Technology Corporation20100
K092902U-Right TD-4238 and TD-4246 Blood Glucose Monitoring System Fora G31 Blood Glucose…Taidoc Technology Corporation20100
K093712Fora G71A Blood Glucose Monitoring System, TD-4274 Blood Glucose Monitoring SystemTaidoc Technology Corporation20100

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, K094005 (Taidoc Technology Corporation, 2010) has gone furthest, with 11 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. 2009, 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 FORA G30 Blood glucose monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and 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 FORA G30 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K090187: Fora G30 Blood Glucose Monitoring System, Model TD-4241.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090187

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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