510(k) · Cleared
ClearedU-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 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 Jun 27, 2011 as substantially equivalent to K094005 (Taidoc Technology Corporation, 2010) after a 391-day review. Its family tree reaches back 3 generations to 2007. 6 later devices descend from it.
- Decided
- Jun 27, 2011
- Review
- 391 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K070472 (2007). 6 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK070472 Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230…Taidoc Technology Corporation · 2007
- 2 generations backK090187 Fora G30 Blood Glucose Monitoring System, Model TD-4241Taidoc Technology Corporation · 2009
- 1 generation backK094005 Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora…Taidoc Technology Corporation · 2010
- This deviceK101509 U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272…Taidoc Technology Corporation · 2011
- Descendant · cites it directly · 1 of its ownK143467 FORA GD43 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2015
- Descendant · cites it directly · 1 of its ownK113307 GL Goodlife Series Blood Glucose Monitoring SysmtemHmd Biomedical, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK173505 FORA GTel Blood Glucose Monitoring SystemForacare, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK162382 Smart Dongle Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK140150 Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301…Hmd Biomedical, Inc. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K143467FORA GD43 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2015 · cites it directly1descendant
- K113307GL Goodlife Series Blood Glucose Monitoring SysmtemHmd Biomedical, Inc. · 2012 · cites it directly1descendant
- K173505FORA GTel Blood Glucose Monitoring SystemForacare, Inc. · 2018 · 2 generations on0descendants
- K162382Smart Dongle Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2017 · cites it directly0descendants
- K140150Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose…Hmd Biomedical, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K070472 | Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230, Surechek Blood… | Taidoc Technology Corporation | 2007 | — |
| −2 | K090187 | Fora G30 Blood Glucose Monitoring System, Model TD-4241 | Taidoc Technology Corporation | 2009 | — |
| −1 | K094005 | Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora G31B/TD-4256B… | Taidoc Technology Corporation | 2010 | — |
| 0 (this device) | K101509 | U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 Blood… | Taidoc Technology Corporation | 2011 | — |
| +1 | K143467 | FORA GD43 Blood Glucose Monitoring System | Taidoc Technology Corporation | 2015 | — |
| +1 | K113307 | GL Goodlife Series Blood Glucose Monitoring Sysmtem | Hmd Biomedical, Inc. | 2012 | — |
| +2 | K173505 | FORA GTel Blood Glucose Monitoring System | Foracare, Inc. | 2018 | — |
| +1 | K162382 | Smart Dongle Blood Glucose Monitoring System | Taidoc Technology Corporation | 2017 | — |
| +2 | K140150 | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose… | Hmd Biomedical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 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 |
|---|---|---|---|
| * | K094005 | Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora G31B/TD-4256B Blood Glucose…Summary page 6…V Blood Glucose Monitoring Systems are substantially equivalent to the predicate device FORA G31 Blood Glucose Monitoring System (K094005). 7. Performance Studies The laboratory and clinical studies for the system performance of U-RIGHT TD-4279 N/B Blood Glucose Mon… | 2010 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143467 | FORA GD43 Blood Glucose Monitoring System | 2015 | 1 |
| K113307 | GL Goodlife Series Blood Glucose Monitoring Sysmtem | 2012 | 1 |
| K162382 | Smart Dongle Blood Glucose Monitoring System | 2017 | 0 |
| K121433 | Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood… | 2013 | 0 |
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 4 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K143467 (Taidoc Technology Corporation, 2015) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K094005.
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. 2011, 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?
The U-Right TD-4279A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-Right TD-4279A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as…
Read the full statement (1,023 words)
The U-Right TD-4279A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared.
The U-Right TD-4279A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The U-Right TD-4279 A Test Strips are for use with the U-Right TD-4279A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The U-Right TD-4279B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared.
The U-Right TD-4279B Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The U-Right TD-4279B Test Strips are for use with the U-Right TD-4279B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The FORA GD4Oa/TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared.
The FORA GD4Oa/TD-4272A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The FORA GD4Oa/TD-4272A Test Strips are for use with the FORA GD4Oa / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The FORA GD4Ob/TD-4272B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared.
The FORA GD4Ob/TD-4272B Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use.
The FORA GD4Ob/TD-4272B Test Strips are for use with the FORA GD4Ob/TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The U-Right TD-4279A MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
The U-Right TD-4279A MULTI Test Strips are for use with the U-Right TD-4279A MULTI Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.
The U-Right TD-4279B MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
The U-Right TD-4279B MULTI Test Strips are for use with the U-Right TD-4279B MULTI Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.
The FORA Wisdom GD4Oa/TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
The FORA Wisdom GD4Oa / TD-4272A Test Strips are for use with the FORA Wisdom GD4Oa / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.
The FORA Wisdom GD4Ob/TD-4272B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus.
The FORA Wisdom GD4Ob/TD-4272B Test Strips are for use with the FORA Wisdom GD4Ob/TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101509: U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 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/K101509
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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