510(k) · Cleared
ClearedFora V10 Blood Glucose Monitoring System, Model TD-4244
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 24, 2009 as substantially equivalent to K090404 (Taidoc Technology Corporation, 2009) after an 85-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Dec 24, 2009
- Review
- 85 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K090404 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK090404 Fore V10 Blood Glucose Monitoring System, Model TD-4244, Forea V12…Taidoc Technology Corporation · 2009
- This deviceK093035 Fora V10 Blood Glucose Monitoring System, Model TD-4244Taidoc Technology Corporation · 2009
- Descendant · cites it directly · 0 of its ownK121706 Fora V10 Blood Glucose Monitoring SystemForacare, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K121706Fora V10 Blood Glucose Monitoring SystemForacare, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K090404 | Fore V10 Blood Glucose Monitoring System, Model TD-4244, Forea V12 Blodo… | Taidoc Technology Corporation | 2009 | — |
| 0 (this device) | K093035 | Fora V10 Blood Glucose Monitoring System, Model TD-4244 | Taidoc Technology Corporation | 2009 | — |
| +1 | K121706 | Fora V10 Blood Glucose Monitoring System | Foracare, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K090404 | Fore V10 Blood Glucose Monitoring System, Model TD-4244, Forea V12 Blodo Glucose…Summary page 2…e Pack. 5. Substantial Equivalance Information: A. Predicate device name: Fora VI1O Blood Glucose Monitoring System, Model TD-4244 B. Predicate K number: K090404 C. Comparison with predicate: The modified FORA VICO Blood Glucose Monitoring System has the following similarities… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121706 | Fora V10 Blood Glucose Monitoring System | 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?
- Its one ancestor has no recall.
- Of its descendants, K121706 (Foracare, Inc., 2013) has gone furthest, with 0 descendants of its own.
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. 2009, 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 V10 Blood Glucdse Monitoring System, Model TD-4244 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 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 V10 Blood Glucose Monitoring System, Model TD-4244 can be used only during steady-state blood glucose conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093035: Fora V10 Blood Glucose Monitoring System, Model TD-4244.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093035
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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