# K092052: Rightest Blood Glucose Monitoring System, Model GM550

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Corporation
- Decided: Jun 18, 2010 after 346 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.
10 later devices descend from it; 3 cite it directly.
0 of 15 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
- 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
- K120423: Bionime Rightest Blood Glucose Monitoring System, Model GM650 (2012), 3 descendants of its own
- K123008: Rightest Blood Glucose Monitoring System GM700 GE GE200 Blood Glucose Monitoring System Rightest Blood Glucose Monitorin (2013), 2 descendants of its own
- K170143: GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, (2017), 1 descendant of its own

## Indications for use
The Rightest Blood Glucose Monitoring System, Model GM550 is intended for the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm by professional healthcare personnel in clinical settings or diabetics at home to measure the glucose concentration for aiding diabetes management. This device is not intended for testing neonate blood samples and is not intended for the diagnosis of or screening for diabetes mellitus. Rightest Blood Glucose Test Strips GS550 are intended for use with the Rightest GM550 Blood Glucose meter in the quantitative measurement of glucose in capillary whole blood from the fingertip, palm and forearm. Rightest Control Solutions are intended for use with the Rightest Blood Glucose Monitoring System, Model GM550 to check that both the glucose meters and test strips are working properly. These solutions contain a known range of glucose, as indicated on the bottles.

Source page: https://510kreport.com/device/K092052
Methodology: https://510kreport.com/methodology