DeviceClearance

Product code QRX— Clinical Chemistry

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Classification name
Continuous Glucose Monitor Informed Insulin Dose Calculator
Device class
Class 2
Regulation
21 CFR 862.1358
Advisory panel
Clinical Chemistry
Total cleared
6
First cleared
Most recent

FDA classification definition

“A continuous glucose monitor (CGM)-informed insulin dose calculator is a software device that calculates suggested insulin doses based on CGM values and/or other relevant information.”

— U.S. Food and Drug Administration, device classification record for product code QRX under 21 CFR 862.1358, via openFDA

Market context for product code QRX

FDA has cleared 6 devices under product code QRX between 2022 and 2026, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QRX

Recent clearances under product code QRX

Data sourced from openFDA. This site is unofficial and independent of the FDA.