# K081451: Rightest Blood Glucose Monitoring System, Model GM100

- Pathway: 510(k) (Special)
- Applicant: Bionime Corporation
- Decided: Sep 18, 2008 after 118 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.
2 later devices descend from it; 1 cites it directly.
0 of 7 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.

## Most influential descendants
- K102751: Labonacheck Gluppy Blood Glucose Monitoring System (2013), 1 descendant of its own
- K140141: Labonacheck Gluppy Blood Glucose Monitoring System (2014), 0 descendants of its own

## 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/K081451
Methodology: https://510kreport.com/methodology