# K081796: Easyplus Mini R2N Self Monitoring Glucose Test System

- Pathway: 510(k) (Traditional)
- Applicant: Eps Bio Technology Corp.
- Decided: Jan 23, 2009 after 212 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: 6 generations back to K945887 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061992: Easyplus Self Monitoring Glucose Test System, Model EPS04014, Eps Bio Technology Corp. (2006) Summary page 3.

## Indications for use
The EasyPlus mini R2N 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 momtor the effectiveness of diabetes control The EasyPlus min R2N Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm EasyPlus mini R2N Blood Glucose Test Strips must be used with the EasyPlus mini R2N Meter 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 morntor the effectiveness of diabetes control The EasyPlus miraR2N Blood Glucose Test Strips, are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm EasyPlus mini R2N Blood Glucose Test Strips must be used with the EasyPlus mini R2N Blood Glucose Meter Testing is done outside the body (In Vitro diagnostic use) They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monmtor the effectiveness of diabetes control For use with the EasyPlus mumn R2N meter and EasyPlus mini R2N Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results

Source page: https://510kreport.com/device/K081796
Methodology: https://510kreport.com/methodology