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, Welldoc, Inc. and Dexcom, Inc..
6
Total
6
Cleared
197d
Avg days
2022
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg
159d
recently vs 216d historically
FDA 510(k) Cleared Continuous Glucose Monitor Informed Insulin Dose Calculator Devices (Product Code QRX)
6 devices
Cleared
Sep 08, 2026
MODI System
DreaMed Diabetes, Ltd.
Chemistry
243d
Cleared
Nov 18, 2025
Dexcom Smart Basal
Dexcom, Inc.
Chemistry
75d
Cleared
Oct 18, 2023
SmartBolus Calculator
Insulet Corporation
Chemistry
119d
Cleared
Aug 11, 2023
BlueStar CGM insulin dose calculator
Welldoc, Inc.
Chemistry
322d
Cleared
Aug 19, 2022
SmartBolus Calculator
Insulet Corporation
Chemistry
24d
Cleared
Jan 27, 2022
Omnipod 5 SmartBolus Calculator
Insulet Corporation
Chemistry
400d
About Product Code QRX - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code QRX since 2022, with 6 receiving FDA clearance (average review time: 197 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - QRX Product Code
Recent submissions under QRX have taken an average of 159 days to reach a decision - down from 216 days historically, suggesting improved FDA processing for this classification.
QRX devices are reviewed by the Chemistry panel. Browse all Chemistry devices →