# K143387: GE333 Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Coporation
- Decided: Jun 3, 2015 after 189 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: 5 generations back to K024194 (2003). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092052: Rightest Blood Glucose Monitoring System, Model GM550, Bionime Corporation (2010) Summary page 5.

## Most influential descendants
- 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
- K173139: Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus (2018), 0 descendants of its own
- K161790: iGlucose Blood Glucose Monitoring System (2017), 0 descendants of its own

## Indications for use
The GE Blood Glucose Monitoring System 333 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 GE Blood Glucose Monitoring System 333 is intended to be used by a single person and should not be shared. The GE Blood Glucose Monitoring System 333 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 GE Blood Glucose Monitoring System 333 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 GE Blood Glucose Test Strips 333 are for use with the GE Blood Glucose Meter 333 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Source page: https://510kreport.com/device/K143387
Methodology: https://510kreport.com/methodology