QJS

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Interoperable Automated Glycemic Controller, Insulin Suspend

Device class

Class II (moderate risk)

Regulation

21 CFR 862.1356

Medical specialty

Clinical Chemistry

FDA definition

An interoperable automated glycemic controller, insulin suspend, is a device that temporarily suspend and resumes insulin infusion from a connected infusion pump based on specified thresholds and input glucose levels. Interoperable automated glycemic controllers, insulin suspend, are designed to reliably and securely communicate with digitally connected devices to allow insulin delivery suspension and resumption commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers, insulin suspend, are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.

Adverse events (MAUDE)

2026: 92
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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