510(k) · Cleared
ClearedFora Poct S10/TD-4258 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 Jul 6, 2011 as substantially equivalent to K082169 (Taidoc Technology Corporation, 2008) after a 673-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Jul 6, 2011
- Review
- 673 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K031755 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK031755 Accu-Chek Compact Test StripRoche Diagnostics Corp. · 2003
- 2 generations backK040796 Accu-Chek GO SystemRoche Diagnostics Corp. · 2004 · Recalled
- 1 generation backK082169 Pro Glucose Test StripTaidoc Technology Corporation · 2008
- This deviceK092688 Fora Poct S10/TD-4258 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 | K031755 | Accu-Chek Compact Test Strip | Roche Diagnostics Corp. | 2003 | — |
| −2 | K040796 | Accu-Chek GO System | Roche Diagnostics Corp. | 2004 | 2 |
| −1 | K082169 | Pro Glucose Test Strip | Taidoc Technology Corporation | 2008 | — |
| 0 (this device) | K092688 | Fora Poct S10/TD-4258 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 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 |
|---|---|---|---|
| * | K082169 | Pro Glucose Test StripSummary page 1…n/Usual Name: Blood Glucose Test System Manufacturer TaiDoc Technology Corporation 510 (k)Number K(082169 4. Device Description The FORA POCT S1l0 Blood Glucose Monitoring System is designed to quantitatively measure the concentration… | 2008 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K082169.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 FORA POCT 310 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. It is indicated for multiple patients use by health care professionals in health care facilities as an aid in monitoring the effectiveness of diabetes control program. The system is only used with single-use lancing devices. It is not intended for the diagnosis of…
Read the full statement (134 words)
The FORA POCT 310 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. It is indicated for multiple patients use by health care professionals in health care facilities as an aid in monitoring the effectiveness of diabetes control program. The system is only used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus. It is not intended for use on neonates.
The FORA POCT 31 0 Blood Glucose test strips are for the quantitative measurement of glucose with fresh capillary whole blood from the finger and venous whole blood samples. The FORA POCT S10 test strips are for use only with the FORA POCT S10 Blood Glucose meter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092688: Fora Poct S10/TD-4258 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/K092688
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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