DeviceClearance

Product code QBJ— Clinical Chemistry

Dexcom G7 Continuous Glucose Monitoring System

Classification name
Integrated Continuous Glucose Monitoring System, Factory Calibrated
Device class
Class 2
Regulation
21 CFR 862.1355
Advisory panel
Clinical Chemistry
Total cleared
18
First cleared
Most recent

FDA classification definition

“An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.”

— U.S. Food and Drug Administration, device classification record for product code QBJ under 21 CFR 862.1355, via openFDA

Market context for product code QBJ

FDA has cleared 18 devices under product code QBJ between 2018 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QBJ

Adverse events under product code QBJ

product code QBJ
Death
180
Injury
31,825
Malfunction
1,792,244
Other
36
Total
1,824,285

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QBJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.