# K112963: TD-4257 Blood Glucose Monitoring Systems,TD 4257 Multi Blood Glucose Monitoring Systems

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Nov 22, 2011 after 48 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)
- K101635: TD-4239 Blood Glucose Monitoring System  and TD-4239 Multi Blood Glucose Monitoring System, Taidoc Technology Corporation (2011) Summary page 3.

## Indications for use
The TD-4257 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared. The TD-4257 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. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates. The TD-4257 Blood Glucose Test Strips are for use with the TD-4257 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples. The TD-4257 Multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary, venous and neonatal whole blood samples. The TD-4257 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple patient use in professional healthcare settings as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. Professionals may test with capillary, venous and neonatal whole blood. Capillary samples may be drawn from the fingertip, and in the case of neonates, from the heel. The system is only used with single-use, auto-disabling lancing devices. The TD-4257 Multi Blood Glucose Test Strips are for use with the TD-4257 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.

Source page: https://510kreport.com/device/K112963
Methodology: https://510kreport.com/methodology