Alternate Controller Enabled Insulin Infusion Pump

What Is This Device?

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.

How Is QFG Classified?

Alternate Controller Enabled Insulin Infusion Pump is FDA product code QFG, Class 2, 21 CFR 880.5730.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 21 recalls under this product code since 2022. None was by a company in China. 8 are Class I, the most serious grade.

The root causes the FDA records most often are Software design (6), Software Design Change (4) and Process design (4). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.