# K042678: Rightest Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Corporation
- Decided: Jan 3, 2005 after 96 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K024194 (2003). 1 ancestor in all.
18 later devices descend from it; 6 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems, Lifescan, Inc. (2003) Summary page 2.

## Most influential descendants
- K053635: Modification to Rightest Blood Glucose Monitoring System (2006), 17 descendants of its own
- K062567: Rightest Blood Glucose Monitoring System (2007), 16 descendants of its own
- K092052: Rightest Blood Glucose Monitoring System, Model GM550 (2010), 10 descendants of its own
- K110737: Rightest Blood Glucose Monitoring System GM700 (2012), 4 descendants of its own
- K143387: GE333 Blood Glucose Monitoring System (2015), 3 descendants of its own

## Recalls of this device
- Nov 26, 2007 · Not classified · Z-0728-2008: Abnormal Memory Recall: When the meter is fixed in 12 hour mode, the time frame display of all memory data will be shown incorrectly as AM or PM depending on when the user is recalling the memory stor

## 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 using capillary whole blood from the fingertip by using Rightest Blood Glucose Monitoring System. This test device is not intended for testing neonate blood samples. Special condition for use statement(s): Rightest System provides plasma equivalent results.

Source page: https://510kreport.com/device/K042678
Methodology: https://510kreport.com/methodology