510(k) · Cleared
ClearedU-Right TD-4280 Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · LFR Glucose Dehydrogenase, Glucose
Cleared on Apr 12, 2012 as substantially equivalent to K100322 (Taidoc Technology Corporation, 2010) after a 113-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Apr 12, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K031755 (2003). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK031755 Accu-Chek Compact Test StripRoche Diagnostics Corp. · 2003
- 3 generations backK040796 Accu-Chek GO SystemRoche Diagnostics Corp. · 2004 · Recalled
- 2 generations backK082169 Pro Glucose Test StripTaidoc Technology Corporation · 2008
- 1 generation backK100322 TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation · 2010
- This deviceK113768 U-Right TD-4280 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K031755 | Accu-Chek Compact Test Strip | Roche Diagnostics Corp. | 2003 | — |
| −3 | K040796 | Accu-Chek GO System | Roche Diagnostics Corp. | 2004 | 2 |
| −2 | K082169 | Pro Glucose Test Strip | Taidoc Technology Corporation | 2008 | — |
| −1 | K100322 | TD-4277 Blood Glucose Monitoring System, Model 4277 | Taidoc Technology Corporation | 2010 | — |
| 0 (this device) | K113768 | U-Right TD-4280 Blood Glucose Monitoring System | Taidoc Technology Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 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 LFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K100322 | TD-4277 Blood Glucose Monitoring System, Model 4277Summary page 2…blood glucose test results. *5. Substantial Equivalence Information: A. Predicate device name: TD-4277 Blood Glucose Monitoring System B. Predicate K number: K 100322 C. Comparison with predicate: The modified U-RIGHT TD-4280 Blood Glucose Monitoring System has the following… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 9 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 4 other devices also cite its predicate K100322.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LFR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFR
161in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFR
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFR
827in 2025
MAUDE reports naming product code LFR, 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 | 1 | — | 3 | 23,819 |
| 2008 | 0 | — | 1 | 6,584 |
| 2009 | 1 | — | 4 | 10,823 |
| 2010 | 0 | — | 0 | 4,865 |
| 2011 | 6 | 296 | 1 | 3,802 |
| 2012 | 13 | 152 | 1 | 3,341 |
| 2013 | 3 | 212 | 0 | 3,821 |
| 2014 | 3 | 161 | 0 | 3,960 |
| 2015 | 1 | — | 0 | 3,366 |
| 2016 | 0 | — | 0 | 2,145 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 108 |
| 2019 | 0 | — | 0 | 108 |
| 2020 | 0 | — | 0 | 132 |
| 2021 | 0 | — | 0 | 164 |
| 2022 | 0 | — | 0 | 101 |
| 2023 | 0 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 171 |
| 2025 | 0 | — | 0 | 827 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The U-RIGHT TD-4280 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. Itris intended to be used by a single person and should not be shared. The U-RIGI-T TD-4280 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.…
Read the full statement (136 words)
The U-RIGHT TD-4280 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. Itris intended to be used by a single person and should not be shared.
The U-RIGI-T TD-4280 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. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates. The meter contain s speaking functions but is not intended for use by visually impaired users.
The U-RIGHT TD-4280 Blood Glucose Test Strips are for use with the U-RIGHT TD-4280 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113768: U-Right TD-4280 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/K113768
Report an extraction error
Are you the manufacturer?
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