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, Inc..
FDA 510(k) Cleared Interoperable Automated Glycemic Controller Devices (Product Code QJI)
About Product Code QJI - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code QJI since 2019, with 19 receiving FDA clearance (average review time: 188 days).
Submission volume has increased in recent years - 11 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QJI have taken an average of 136 days to reach a decision - down from 251 days historically, suggesting improved FDA processing for this classification.
QJI devices are reviewed by the Chemistry panel. Browse all Chemistry devices →