Cleared Traditional

SmartBolus Calculator

K231824 · Insulet Corporation · Chemistry
Oct 2023
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K231824 is an FDA 510(k) clearance for the SmartBolus Calculator, a Continuous Glucose Monitor Informed Insulin Dose Calculator (Class II — Special Controls, product code QRX), submitted by Insulet Corporation (Acton, US). The FDA issued a Cleared decision on October 18, 2023, 119 days after receiving the submission on June 21, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1358.

Submission Details

510(k) Number K231824 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2023
Decision Date October 18, 2023
Days to Decision 119 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.