FDA Product Code QCC: Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals
An Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals Is Intended To Recommend Insulin Pump Therapy Parameter Adjustments (e.g., Basal Rate, Insulin To Carbohydrate Ratios, Insulin Sensitivity Factors) Based On Data From External Devices, Including Continuous Glucose Monitors.
Leading manufacturers include DreaMed Diabetes, Ltd..
FDA 510(k) Cleared Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals Devices (Product Code QCC)
About Product Code QCC - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QCC since 2018, with 4 receiving FDA clearance (average review time: 137 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QCC devices are reviewed by the Chemistry panel. Browse all Chemistry devices →