# K173345: TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: May 4, 2018 after 192 days
- Product code: JIN (Nitroprusside, Ketones (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K945887 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161738: FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems, Taidoc Technology Corporation (2016) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K173345
Methodology: https://510kreport.com/methodology