510(k) · Cleared
ClearedSmart Dongle 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 Apr 14, 2017 as substantially equivalent to K101509 (Taidoc Technology Corporation, 2011) after a 233-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Apr 14, 2017
- Review
- 233 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K070472 (2007). No later device cites it as a predicate yet.
- Root · 4 generations backK070472 Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230…Taidoc Technology Corporation · 2007
- 3 generations backK090187 Fora G30 Blood Glucose Monitoring System, Model TD-4241Taidoc Technology Corporation · 2009
- 2 generations backK094005 Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora…Taidoc Technology Corporation · 2010
- 1 generation backK101509 U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272…Taidoc Technology Corporation · 2011
- This deviceK162382 Smart Dongle Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K070472 | Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230, Surechek Blood… | Taidoc Technology Corporation | 2007 | — |
| −3 | K090187 | Fora G30 Blood Glucose Monitoring System, Model TD-4241 | Taidoc Technology Corporation | 2009 | — |
| −2 | K094005 | Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora G31B/TD-4256B… | Taidoc Technology Corporation | 2010 | — |
| −1 | K101509 | U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 Blood… | Taidoc Technology Corporation | 2011 | — |
| 0 (this device) | K162382 | Smart Dongle Blood Glucose Monitoring System | Taidoc Technology Corporation | 2017 | — |
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 |
|---|---|---|---|
| * | K101509 | U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 Blood Glucose…Summary page 4…exempt Regulation Citation: 21 CFR §862.1345 21 CFR §862.2100 3. Predicate Device U-RIGHT TD-4279 blood glucose monitoring system (k101509) 4. Intended Use The Smart Dongle Blood Glucose Monitoring System consists of the Smart Dongle meter, single use… | 2011 |
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 10 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K101509.
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. 2017, 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 Smart Dongle Blood Glucose Monitoring System consists of the Smart Dongle meter, single use Smart Dongle test strips, and the Smart Dongle mobile application as the display component of the Smart Dongle Blood Glucose Monitoring System. The Smart Dongle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger. This blood glucose monitoring system is…
Read the full statement (135 words)
The Smart Dongle Blood Glucose Monitoring System consists of the Smart Dongle meter, single use Smart Dongle test strips, and the Smart Dongle mobile application as the display component of the Smart Dongle Blood Glucose Monitoring System. The Smart Dongle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger. This blood glucose monitoring system is intended to be used by a single person and should not be shared. Smart Dongle Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162382: Smart Dongle 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/K162382
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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