# K113077: Bioland G-423 Glood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Taidoc Technology Corporation
- Decided: Aug 3, 2012 after 291 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: 2 generations back to K042005 (2004). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053593: Prodigy, Diagnostic Devices, Inc. (2006) Summary page 2.

## Most influential descendants
- K191657: Bioland Blood Glucose Monitoring System (2020), 1 descendant of its own
- K202739: Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System (2022), 0 descendants of its own

## Indications for use
The Bioland 0-423 BLOOD GLUCOSE MONITORING SYSTEM is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This system is intended to be used by a single person and should not be shared. The Bioland G-423 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. The Bioland G-423 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The Bioland G-423 Test Strips are for use with the Bioland 0-423 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Source page: https://510kreport.com/device/K113077
Methodology: https://510kreport.com/methodology