510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QRXClass II

Continuous Glucose Monitor Informed Insulin Dose Calculator

21 CFR 862.1358 / Clinical Chemistry
FDA source (opens on fda.gov)

QRX is the FDA product code for Continuous Glucose Monitor Informed Insulin Dose Calculator, a class II device type, regulated under 21 CFR 862.1358. FDA's definition for this code reads: "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". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
QRX
Device name
Continuous Glucose Monitor Informed Insulin Dose Calculator
FDA 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.
Regulation
21 CFR 862.1358
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
2

Clearances, product code QRX

By decision year
6 clearances under product code QRX with a decision year between 2022 and 2026, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QRX by decision year
YearClearances
20222
20232
20251
20261

Applicants with the most clearances

Product code QRX
Applicants holding the most 510(k) clearances under product code QRX
ApplicantClearances
Insulet Corporation3
Dexcom, Inc.1
DreaMed Diabetes, Ltd.1
Welldoc1

Companies listing this code with FDA

Companies whose registered establishments list this code