510(k) · Cleared
ClearedTD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Cleared on May 4, 2018 as substantially equivalent to K161738 (Taidoc Technology Corporation, 2016) after a 192-day review. Its family tree reaches back 8 generations to 1995. 1 of the 16 devices in its family, counting itself, has a Class I recall.
- Decided
- May 4, 2018
- Review
- 192 days
- Class
- Class I
- Product code
- JIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945887 (1995). 15 ancestors in all, the oldest K850368 (1985). No later device cites it as a predicate yet. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 7 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 6 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 5 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 4 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 3 generations backK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- 2 generations backK091547 Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max…Nova Biomedical Corp. · 2010 · Recalled (Class I)
- 1 generation backK161738 FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and…Taidoc Technology Corporation · 2016
- This deviceK173345 TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology Corporation · 2018
Class I recalls in this family
- K091547 Nova Max Plus Blood Glucose and B-Ketone Monitor…2 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −7 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −6 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −5 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −4 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −3 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| −2 | K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus… | Nova Biomedical Corp. | 2010 | Class I |
| −1 | K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone… | Taidoc Technology Corporation | 2016 | — |
| 0 (this device) | K173345 | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System | Taidoc Technology Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2007 | 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.
1 device in this family has a Class I recall. 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 JIN device
- #1 K192957 VivaChek Blood Glucose and B-Ketone Monitoring…score 1.6 · 8 generations · no Class I recall
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 |
|---|---|---|---|
| * | K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring…Summary page 4…ssification 21 CFR §862.1435 Ketones (nonquantitative) test system Regulation Citation Meets limitations of exemptions 21 CFR 862.9(c)(5) 3. Predicate Device k161738 FORA ADVANCED GD40 Blood Glucose and β-Ketone Monitoring System TaiDoc Technology Corporation… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 2010 · 2 generations back · ◆ on the line of descent in FIG. 110 Class I recalls
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K161738.
How does its category compare?
All JIN devicesJIN Nitroprusside, Ketones (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · JIN
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JIN
192in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIN
3in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIN
4in 2025
MAUDE reports naming product code JIN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 192 | 0 | 5 |
| 2019 | 0 | — | 0 | 52 |
| 2020 | 2 | — | 0 | 37 |
| 2021 | 0 | — | 0 | 43 |
| 2022 | 0 | — | 1 | 14 |
| 2023 | 0 | — | 3 | 17 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The TD-4140 Smart Dongle Blood Glucose plus β-ketone Monitoring System consists of the Smart Dongle meter, Smart Dongle blood glucose test strips, Smart Dongle β-ketone test strips, and the Procheck mobile application as the display component of the system. This system is intended to be used for the quantitative measurement of glucose (sugar) and β-ketone in fresh capillary whole blood from the finger. This system is intended for self-testing outside the…
Read the full statement (126 words)
The TD-4140 Smart Dongle Blood Glucose plus β-ketone Monitoring System consists of the Smart Dongle meter, Smart Dongle blood glucose test strips, Smart Dongle β-ketone test strips, and the Procheck mobile application as the display component of the system. This system is intended to be used for the quantitative measurement of glucose (sugar) and β-ketone in fresh capillary whole blood from the finger.
This 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. It is intended to be used by a single person and should not be shared. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173345 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173345: TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173345
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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