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..
5
Total
4
Cleared
137d
Avg days
2018
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals Devices (Product Code QCC)
5 devices
Cleared
Oct 03, 2023
endo.digital Platform
DreaMed Diabetes, Ltd.
Chemistry
28d
Cleared
Sep 28, 2021
Advisor Pro Platform
DreaMed Diabetes, Ltd.
Chemistry
215d
Cleared
Aug 28, 2020
DreaMed Advisor Pro
DreaMed Diabetes, Ltd.
Chemistry
86d
Cleared
Jul 18, 2019
DreaMed Advisor Pro
DreaMed Diabetes, Ltd.
Chemistry
57d
Not Cleared
Jun 12, 2018
DreaMed Advisor Pro
DreaMed Diabetes, Ltd.
Chemistry
299d
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.