510(k) · Cleared
ClearedFora TD-4244 & TD-4245 Blood Glucose Monitoring Systesm
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 17, 2008 after a 182-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 17, 2008
- Review
- 182 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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. 2008, 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 TD-4244 Blood Glucose Monitoring System is intmded for use in the quantitative measurement of glucose in fresh capillary whole blood :from the finger BOd the following alternative s~es: the palm, the forearm. the upper-arm, the calf and the thigh. It is .intended for use by healtbcm professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not iDteildCd for the diagnosis…
Read the full statement (130 words)
The FORA TD-4244 Blood Glucose Monitoring System is intmded for use in the quantitative measurement of glucose in fresh capillary whole blood :from the finger BOd the following alternative s~es: the palm, the forearm. the upper-arm, the calf and the thigh. It is .intended for use by healtbcm professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not iDteildCd for the diagnosis ofor screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the FORA TD-4244 Blood Glucose Monitoring System can be used only during steady-state blood glUC0ge conditions.
The FORA ID-4244 Blood Glucose Monitoring System contains a speaking functicmality which provides step by step instnJctions to aid visually impaired persons.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K081715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081715: Fora TD-4244 & TD-4245 Blood Glucose Monitoring Systesm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081715
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026