510(k) · Cleared
ClearedFora V10 Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foracare, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Jan 14, 2013 as substantially equivalent to K093035 (Taidoc Technology Corporation, 2009) after a 220-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- Jan 14, 2013
- Review
- 220 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K090404 (2009). No later device cites it as a predicate yet.
- Root · 2 generations backK090404 Fore V10 Blood Glucose Monitoring System, Model TD-4244, Forea V12…Taidoc Technology Corporation · 2009
- 1 generation backK093035 Fora V10 Blood Glucose Monitoring System, Model TD-4244Taidoc Technology Corporation · 2009
- This deviceK121706 Fora V10 Blood Glucose Monitoring SystemForacare, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K090404 | Fore V10 Blood Glucose Monitoring System, Model TD-4244, Forea V12 Blodo… | Taidoc Technology Corporation | 2009 | — |
| −1 | K093035 | Fora V10 Blood Glucose Monitoring System, Model TD-4244 | Taidoc Technology Corporation | 2009 | — |
| 0 (this device) | K121706 | Fora V10 Blood Glucose Monitoring System | Foracare, Inc. | 2013 | — |
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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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 |
|---|---|---|---|
| * | K093035 | Fora V10 Blood Glucose Monitoring System, Model TD-4244Summary page 2…O No Code Blood Glucose Monitoring System, model TD-4244, can be used only during steady-state blood glucose conditions. 4. The Indications for Use is identical to K093035. The Indications for Use can be found in Section 8. 5. Device Description: The system consists of three main products: the… | 2009 |
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 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
FORA VIG No Code Blood Glucose 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: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. The meter contains some speaking functions but…
Read the full statement (218 words)
FORA VIG No Code Blood Glucose 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: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. The meter contains some speaking functions but has not been validated for use by visually impaired users. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
This system is intended to be used by a single patient and should not be shared.
FORA VIO0 test strips are for use with FORA VI10 No Code Blood Glucose meter model TD-4244 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from fingertips, palm, forearm, upper arm calf and thigh.
The FORA control solutions can only be used with FOR-A VI10 No Code Blood Glucose meter, model TD-4244 and the FORA VI10 test strips to check that meter and test strips are working together properly.
The alternative site testing in FORA VIO No Code Blood Glucose Monitoring systems 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/K121706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121706: Fora 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/K121706
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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