QFG

Alternate Controller Enabled Insulin Infusion Pump

Product code

QFG

Device name

Alternate Controller Enabled Insulin Infusion Pump

Device class

Class 2

21 CFR

21 CFR 880.5730

Medical specialty

Clinical Chemistry

Marketing pathway

510(K)

510(k) clearances (last 3 years)

18

Summaries archived here

17 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.

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

510(k) clearances, last 3 years (18)

Last three years. Most recent: 2026-06-17.

17 summaries are archived here for direct download.