510(k) · Cleared
ClearedFora Premium V10 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 Dec 15, 2011 as substantially equivalent to K093635 (Taidoc Technology Corporation, 2010) after a 129-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Dec 15, 2011
- Review
- 129 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K070472 (2007). No later device cites it as a predicate yet.
- 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 backK093635 Models Fora V30 and TD-4242 Blood Glucose Monitoring SystemsTaidoc Technology Corporation · 2010
- This deviceK112275 Fora Premium V10 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2011
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 | K093635 | Models Fora V30 and TD-4242 Blood Glucose Monitoring Systems | Taidoc Technology Corporation | 2010 | — |
| 0 (this device) | K112275 | Fora Premium V10 Blood Glucose Monitoring System | Taidoc Technology Corporation | 2011 | — |
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 |
|---|---|---|---|
| * | K093635 | Models Fora V30 and TD-4242 Blood Glucose Monitoring SystemsSummary page 2…Glucose Monitoring System. 5. Substantial Equivalence Information: A. Predicate device name: FORA V30 blood glucose monitoring system B. Predicate K number: K093635 C. Comparison with predicate: The modified FORA Premium V1O Blood Glucose Monitoring System has the following simila… | 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 4 years and passes through 1 company; a new generation was cleared every 1.8 years on median.
- None of the 3 ancestors has a recall.
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 FORA Premium VIG 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: palm, forearm, upper-arm, calf and thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring thle effectiveness of diabetes control program. This system is intended to be used by a single person and should not be shared.…
Read the full statement (174 words)
The FORA Premium VIG 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: palm, forearm, upper-arm, calf and thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring thle effectiveness of diabetes control program. This system is intended to be used by a single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mnellitus, and is not intended for use on neonates.
The alternative site testing in the FORA Premium VIC Blood Glucose Monitoring System canl be used only during steady-state blood glucose conditions.
The FORA premium V1O Test Strips are for use with the FORA Premium V 10 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samp~les drawn from the fingertip, palm, forearm, upper-armn, calf and thigh.
This meter has some speaking functions but is not intended for use by the visually impaired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112275: Fora Premium V10 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/K112275
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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