DeviceClearance

Product code QDK— Clinical Chemistry

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System

Classification name
Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
Device class
Class 2
Regulation
21 CFR 862.1355
Advisory panel
Clinical Chemistry
Total cleared
4
First cleared
Most recent

FDA classification definition

“An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.”

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

Market context for product code QDK

FDA has cleared 4 devices under product code QDK between 2018 and 2021, filed by 1 applicant company. 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 QDK

Adverse events under product code QDK

product code QDK
Malfunction
578
Total
578

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 QDK

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