FDA Product Code QFG: Alternate Controller Enabled Insulin Infusion Pump
Under FDA product code QFG, alternate controller enabled (ACE) insulin infusion pumps are cleared for integration with external automated insulin delivery systems.
These insulin pumps are designed with standardized communication interfaces that allow third-party controllers — including smartphones and closed-loop algorithms — to adjust insulin delivery. They are a key component of artificial pancreas systems that automate glycemic management in diabetes.
QFG devices are Class II medical devices, regulated under 21 CFR 880.5730 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Tandem Diabetes Care, Inc., Medtronic Minimed, Inc. and Insulet Corporation.
FDA 510(k) Cleared Alternate Controller Enabled Insulin Infusion Pump Devices (Product Code QFG)
About Product Code QFG - Regulatory Context
510(k) Submission Activity
27 total 510(k) submissions under product code QFG since 2019, with 26 receiving FDA clearance (average review time: 170 days).
Submission volume has remained relatively stable over the observed period, with 11 submissions in the last 24 months.
FDA Review Time
Recent submissions under QFG have taken an average of 98 days to reach a decision - down from 219 days historically, suggesting improved FDA processing for this classification.
QFG devices are reviewed by the Chemistry panel. Browse all Chemistry devices →