# K110435: Easygluco Plus Blood Glucose Monitoring System

- Pathway: 510(k) (Special)
- Applicant: U. S. Diagnostics, Inc.
- Decided: Sep 21, 2011 after 218 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: 3 generations back to K942455 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082201: G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A, U. S. Diagnostics, Inc. (2009) Summary page 1.

## Indications for use
The EasyGluco® Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh as an aid in monitoring the effectiveness of diabetes management in the home by patients with diabetes. The EasyGluco® Plus Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared with any other person. EasyGluco® Plus System is for self testing outside the body (in vitro diagnostic use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The EasyGluco® Plus Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The EasyGluco® Plus Blood Glucose Test Strips are for use with the EasyGluco® Plus Blood Glucose Monitor for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf or thigh.

Source page: https://510kreport.com/device/K110435
Methodology: https://510kreport.com/methodology