510(k) · Cleared
ClearedFora G31A/TD-4256A Blood Glucose Monitoring System and Fora G31B/TD-4256B Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on May 5, 2010 as substantially equivalent to K090187 (Taidoc Technology Corporation, 2009) after a 128-day review. Its family tree reaches back 2 generations to 2007. 11 later devices descend from it.
- Decided
- May 5, 2010
- Review
- 128 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070472 (2007). 11 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK070472 Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230…Taidoc Technology Corporation · 2007
- 1 generation backK090187 Fora G30 Blood Glucose Monitoring System, Model TD-4241Taidoc Technology Corporation · 2009
- This deviceK094005 Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora…Taidoc Technology Corporation · 2010
- Descendant · cites it directly · 6 of its ownK101509 U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272…Taidoc Technology Corporation · 2011
- Descendant · cites it directly · 3 of its ownK101635 TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood…Taidoc Technology Corporation · 2011
- Descendant · 2 generations on · 1 of its ownK143467 FORA GD43 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK113307 GL Goodlife Series Blood Glucose Monitoring SysmtemHmd Biomedical, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK120042 TD-4268 Blood Glucose Monitoring System TD-4268 Multi Blood Glucose…Taidoc Technology Corporation · 2012
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K101509U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 Blood Glucose…Taidoc Technology Corporation · 2011 · cites it directly6descendants
- K101635TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2011 · cites it directly3descendants
- K143467FORA GD43 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2015 · 2 generations on1descendant
- K113307GL Goodlife Series Blood Glucose Monitoring SysmtemHmd Biomedical, Inc. · 2012 · 2 generations on1descendant
- K120042TD-4268 Blood Glucose Monitoring System TD-4268 Multi Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2012 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070472 | Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230, Surechek Blood… | Taidoc Technology Corporation | 2007 | — |
| −1 | K090187 | Fora G30 Blood Glucose Monitoring System, Model TD-4241 | Taidoc Technology Corporation | 2009 | — |
| 0 (this device) | K094005 | Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora G31B/TD-4256B… | Taidoc Technology Corporation | 2010 | — |
| +1 | K101509 | U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 Blood… | Taidoc Technology Corporation | 2011 | — |
| +1 | K101635 | TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose… | Taidoc Technology Corporation | 2011 | — |
| +2 | K143467 | FORA GD43 Blood Glucose Monitoring System | Taidoc Technology Corporation | 2015 | — |
| +2 | K113307 | GL Goodlife Series Blood Glucose Monitoring Sysmtem | Hmd Biomedical, Inc. | 2012 | — |
| +2 | K120042 | TD-4268 Blood Glucose Monitoring System TD-4268 Multi Blood Glucose Monitoring… | Taidoc Technology Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
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 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090187 | Fora G30 Blood Glucose Monitoring System, Model TD-4241Summary page 1…Glucose Monitoring System (Model TD-4241) Common/Usual Name: Blood Glucose Meter Blood Glucose Test Strips Manufacturer TaiDoc Technology Corporation 510 (k) Number K090187 4. Device Description FORA G31a/ TD-4256A Blood glucose monitoring system and FORA G31b/ TD-4256B Blood Glucose Monitoring Syst… | 2009 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101509 (Taidoc Technology Corporation, 2011) has gone furthest, with 6 descendants of its own.
- 7 other devices also cite its predicate K090187.
How does its category compare?
All NBW devicesNBW 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
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
FORA G31a/TD-4256A is intended for in vitro 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…
Read the full statement (368 words)
FORA G31a/TD-4256A is intended for in vitro 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 testing sites in the FORA G31a/TD-4256A Blood Glucose Monitoring system can be used only during steady-state blood glucose conditions.
FORA G31 and TD-4256 Blood Glucose Test Strips are used with the FORA G31a/TD-4256A glucose meter in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the alternative sites specified above.
FORA Control Solutions/Taidoc Control Solutions are intended for use with the FORA G31a/TD-4256A Blood Glucose meter to check that both the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
FORA G31b/TD-4256B is intended for in vitro 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 testing sites in the FORA G31b/TD-4256B Blood Glucose Monitoring system can be used only during steady-state blood glucose conditions.
FORA G31 and TD-4256 Blood Glucose Test Strips are used with the FORA G31b/TD-4256B glucose meter in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the alternative sites specified above.
FORA Control Solutions/Taidoc Control Solutions are intended for use with the FORA G31b/TD-4256B Blood Glucose meter to check that both the glucose meter and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K094005 · printed Nov 4, 2026
Cite this page
510(k) Report. “K094005: Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora G31B/TD-4256B Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K094005
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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