FDA Product Code QRX: Continuous Glucose Monitor Informed Insulin Dose Calculator
FDA product code QRX covers CGM-informed insulin dose calculators that use continuous glucose monitoring data to assist insulin dosing decisions.
These software algorithms incorporate current CGM glucose values, rate of change, and trend data to calculate a suggested insulin dose, providing an additional layer of decision support for patients and clinicians managing insulin therapy.
QRX devices are Class II medical devices, regulated under 21 CFR 862.1358 and reviewed by the FDA Chemistry panel.
Leading manufacturers include Insulet Corporation and Dexcom, Inc..
List of Continuous Glucose Monitor Informed Insulin Dose Calculator devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Continuous Glucose Monitor Informed Insulin Dose Calculator devices (product code QRX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →