# K190564: Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Corporation
- Decided: Jun 2, 2019 after 89 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: 2 generations back to K070585 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140210: Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720, Bionime Corporation (2014) Summary page 6.

## Indications for use
The Rightest Blood Glucose Monitoring System GM700S consists of the Rightest Blood Glucose Monitoring Meter GM700S and the Rightest Blood Glucose Test Strips GS700. The Rightest Blood Glucose Monitoring System GM700S is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700S is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The systems 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 Monitoring System GM700SB consists of the Rightest Blood Glucose Monitoring Meter GM700SB and the Rightest Blood Glucose Test Strips GS700. The Rightest Blood Glucose Monitoring System GM700SB is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700SB is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The systems 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).

Source page: https://510kreport.com/device/K190564
Methodology: https://510kreport.com/methodology