FDA Product Code QDK: Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management
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.
Leading manufacturers include Dexcom, Inc..
FDA 510(k) Cleared Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management Devices (Product Code QDK)
About Product Code QDK - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QDK since 2018, with 4 receiving FDA clearance (average review time: 113 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
QDK devices are reviewed by the Chemistry panel. Browse all Chemistry devices →