# K140210: Rightest Blood Glucose Monitoring System ( GM720, Rightest Professional BGMS GM720

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Corporation
- Decided: Aug 22, 2014 after 206 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: 1 generation back to K070585 (2007). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070585: Accu-Chek Performa System, Roche Diagnostics Corp. (2007) Summary page 8.

## Most influential descendants
- K173638: Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus (2018), 2 descendants of its own
- K231192: RIGHTEST Blood Glucose Monitoring System Max Tel (2024), 1 descendant of its own
- K240637: RIGHTEST Blood Glucose Monitoring System Max Tel (2024), 0 descendants of its own
- K190564: Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB (2019), 0 descendants of its own

## Indications for use
The Rightest Professional Blood Glucose Monitoring System GM720 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 and in venous and arterial whole blood. The Rightest Professional Blood Glucose Monitoring System GM720 is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The Rightest Professional Blood Glucose Monitoring System GM720 should not be used for the diagnosis of, or screening for diabetes, nor for testing neonate blood samples. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The Rightest Professional Blood Glucose Test Strips GS720 are for use with the Rightest Professional Blood Glucose Meter GM720 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm and in venous and arterial whole blood samples. The Rightest Blood Glucose Monitoring System GM720 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 GM720 is intended to be used by a single person and should not be shared. The Rightest Blood Glucose Monitoring System GM720 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM720 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 Test Strips GS720 are for use with the Rightest Blood Glucose Meter GM720 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Source page: https://510kreport.com/device/K140210
Methodology: https://510kreport.com/methodology