QJI

Interoperable Automated Glycemic Controller

Product code

QJI

Device name

Interoperable Automated Glycemic Controller

Device class

Class 2

21 CFR

21 CFR 862.1356

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (last 3 years)

16

Summaries archived here

14 (direct download)

510(k) clearances (all years, FDA)

22 (all years; only the last 3 years are listed here)

FDA classification definition

An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (16)

Last three years. Most recent: 2026-07-09.

14 summaries are archived here for direct download.