# K082020: Envision Blood Glucose Test System

- Pathway: 510(k) (Traditional)
- Applicant: Infopia Co, Ltd.
- Decided: Dec 24, 2008 after 161 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 K950727 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021819: One Touch Ultrasmart Blood Glucose Monitoring System, Lifescan, Inc. (2002) Summary page 1.

## Indications for use
The EnvisionTM Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in capillary whole blood taken from the fingertip, ventral palm, dosal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. ENVISIONTM Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening of diabetes or for neonatal use. Alternate site testing should be done during steady- state times when glucose is not changing rapidly.

Source page: https://510kreport.com/device/K082020
Methodology: https://510kreport.com/methodology