# K173505: FORA GTel Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Foracare, Inc.
- Decided: Aug 9, 2018 after 269 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: 5 generations back to K070472 (2007). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143467: FORA GD43 Blood Glucose Monitoring System, Taidoc Technology Corporation (2015) Summary page 5.

## Indications for use
The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Test Strip and the FORA GTel Blood Glucose meter. The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared.

Source page: https://510kreport.com/device/K173505
Methodology: https://510kreport.com/methodology