FDA Product Code QJI: Interoperable Automated Glycemic Controller
FDA product code QJI covers interoperable automated glycemic controllers — a key component of closed-loop insulin delivery systems for diabetes management.
These software-based controllers automatically calculate and adjust insulin doses based on continuous glucose monitoring data, implementing a control algorithm that mimics the function of a healthy pancreas. They represent the "brain" of automated insulin delivery systems, also known as artificial pancreas technology.
QJI devices are Class II medical devices, regulated under 21 CFR 862.1356 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Insulet Corporation, Tandem Diabetes Care, Inc. and Medtronic Minimed.
List of Interoperable Automated Glycemic Controller devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Interoperable Automated Glycemic Controller devices (product code QJI). 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 →