# K162382: Smart Dongle Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Apr 14, 2017 after 233 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K070472 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101509: U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272  Blood Glucose Monitoring System, Taidoc Technology Corporation (2011) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K162382
Methodology: https://510kreport.com/methodology