Cleared Traditional

BlueStar CGM insulin dose calculator

K222888 · Welldoc, Inc. · Chemistry
Aug 2023
Decision
322d
Days
Class 2
Risk

About This 510(k) Submission

K222888 is an FDA 510(k) clearance for the BlueStar CGM insulin dose calculator, a Continuous Glucose Monitor Informed Insulin Dose Calculator (Class II — Special Controls, product code QRX), submitted by Welldoc, Inc. (Columbia, US). The FDA issued a Cleared decision on August 11, 2023, 322 days after receiving the submission on September 23, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1358.

Submission Details

510(k) Number K222888 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2022
Decision Date August 11, 2023
Days to Decision 322 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code QRX — Continuous Glucose Monitor Informed Insulin Dose Calculator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1358
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.