# K092894: Easymax V  Self Monitoring Blood Glucose System

- Pathway: 510(k) (Special)
- Applicant: Eps Bio Technology Corp.
- Decided: Feb 24, 2010 after 156 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EasyMax V Self Monitoring Blood Glucose Test System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates. The EasyMax V Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons 'Mth diabetes, or in clinical settings by heatthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates. The EasyMax V Blood Glucose Test Strips is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (aver the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. In addition, this device is not intended for the diagnosis of or screening for diabetes and not intended to be used in visually impaired users and neonates. For use with the EasyMax V meter and EasyMax V Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K092894
Methodology: https://510kreport.com/methodology