# K190579: TD-4183 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Jun 4, 2019 after 90 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 K031755 (2003). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100322: TD-4277 Blood Glucose Monitoring System, Model 4277, Taidoc Technology Corporation (2010) Summary page 4.

## Most influential descendants
- K222126: VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System (2024), 0 descendants of its own

## Indications for use
The TD-4183 Blood Glucose Monitoring System consists of the TD-4183 Blood Glucose meter and the TD-4183 Blood Glucose Test Strips. The TD-4183 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the fingertip. This system is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of the diabetes control program. It is intended to be used by single person and should not be shared. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Source page: https://510kreport.com/device/K190579
Methodology: https://510kreport.com/methodology