Cleared Traditional

SmartBolus Calculator

K222239 · Insulet Corporation · Chemistry
Aug 2022
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K222239 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 August 19, 2022, 24 days after receiving the submission on July 26, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1358.

Submission Details

510(k) Number K222239 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2022
Decision Date August 19, 2022
Days to Decision 24 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.