Cleared Traditional

Omnipod 5 SmartBolus Calculator

K203772 · Insulet Corporation · Chemistry
Jan 2022
Decision
400d
Days
Class 2
Risk

About This 510(k) Submission

K203772 is an FDA 510(k) clearance for the Omnipod 5 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 January 27, 2022, 400 days after receiving the submission on December 23, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1358.

Submission Details

510(k) Number K203772 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2020
Decision Date January 27, 2022
Days to Decision 400 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.