# K120423: Bionime Rightest Blood Glucose Monitoring System, Model GM650

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Corporation
- Decided: Aug 3, 2012 after 172 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 K024194 (2003). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092052: Rightest Blood Glucose Monitoring System, Model GM550, Bionime Corporation (2010) Summary page 2.

## Most influential descendants
- K123008: Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose Monitoring System Rightest Blood Glucose Monitorin (2013), 2 descendants of its own
- K141292: Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System (2015), 0 descendants of its own
- K133522: Rightest Diabetes Management Software and Adapter (Existing Cleared K113007),Rightest New Adapters-3,GE Diabetes Managem (2014), 0 descendants of its own

## Indications for use
The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The Rightest Blood Glucose Monitoring System GM650 is intended for single patient use only. The Rightest Blood Glucose Monitoring System GM650 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Rightest Blood Glucose Test Strip GS650 is for use with the Rightest Blood Glucose meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm. The Rightest Control Solution Set GC650 is for use with the Rightest Blood Glucose meter GM650 and Rightest Blood Glucose Test Strips GS65O to check that the meters and test strip are working together properly and that the test is performing correctly. The GE talking blood glucose monitoring system Model GE300 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole samples drawn from the fingertips, palm and forearm. The GE talking blood glucose monitoring system Model GE300 is intended for single patient use only. The GE talking blood glucose monitoring system Model GE300 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE talking blood glucose monitoring system Model GE300 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The GE300 Blood Glucose Test Strip is for use with the GE talking blood glucose monitoring system Model GE300 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm or forearm. The GE300 Control Solution Set is for use with the GE talking blood glucose monitoring system Model GE300 and GE300 Blood Glucose Test Strips to check that the meters and test strip are working together properly and that the test is performing correctly.

Source page: https://510kreport.com/device/K120423
Methodology: https://510kreport.com/methodology