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. and Insulet Corporation.
List of Alternate Controller Enabled Insulin Infusion Pump devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Alternate Controller Enabled Insulin Infusion Pump devices (product code QFG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →