# K072054: Rightest Blood Glucose Monitoring System, Model GM310

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Corporation
- Decided: Feb 28, 2008 after 217 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: 4 generations back to K024194 (2003). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042678: Rightest Blood Glucose Monitoring System, Bionime Corporation (2005) Summary page 2.
- K053635: Modification to Rightest Blood Glucose Monitoring System, Bionime Corporation (2006) Summary page 2.
- K062567: Rightest Blood Glucose Monitoring System, Bionime Corporation (2007) Summary page 2.

## Indications for use
The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring System. This device is not intended for testing neonate blood samples. Special conditions for use statement(s): Rightest System provides plasma equivalent results.

Source page: https://510kreport.com/device/K072054
Methodology: https://510kreport.com/methodology