510(k) · Cleared
ClearedFora Diamond Prima Blood Glucose Monitoring System, Fora Diamond Mini 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 Feb 6, 2012 as substantially equivalent to K100322 (Taidoc Technology Corporation, 2010) after a 220-day review. Its family tree reaches back 4 generations to 2003.
- Decided
- Feb 6, 2012
- Review
- 220 days
- Class
- Class II
- Product code
- NBW
- 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 deviceK111890 Fora Diamond Prima Blood Glucose Monitoring System, Fora Diamond…Taidoc 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) | K111890 | Fora Diamond Prima Blood Glucose Monitoring System, Fora Diamond Mini Blood… | 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 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 |
|---|---|---|---|
| * | K100322 | TD-4277 Blood Glucose Monitoring System, Model 4277Summary page 3…Glucose Monitoring System. 5. Substantial Equivalence Information: A. Predicate device name: TD-4277 blood glucose monitoring system BI. Predicate K number: 1K100322 C. Comparison with predicate: The modified FORA Diamond Prima Blood Glucose Monitoring System and FORA Diamond Mini… | 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 1.6 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 NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
FORA Diamond Prima Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by 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…
Read the full statement (251 words)
FORA Diamond Prima Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by 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.
This system is intended for single-patient use (lay-users at home) and should not be shared.
The FORA Diamond Prima Blood Glucose Test Strips are for use with the FORA Diamond Prima Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
FORA Diamond Mini Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use by 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.
This system is intended for single-patient use and should not be shared.
The FORA Diamond Mini Blood Glucose Test Strips are for use with the FORA Diamond Mini Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111890 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111890: Fora Diamond Prima Blood Glucose Monitoring System, Fora Diamond Mini 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/K111890
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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