Cleared Traditional

Omnipod? Insulin Management System, Omnipod DASH? Insulin Management System

K211575 · Insulet Corporation · Chemistry
Aug 2021
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K211575 is an FDA 510(k) clearance for the Omnipod? Insulin Management System, Omnipod DASH? Insulin Management System, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Insulet Corporation (Acton, US). The FDA issued a Cleared decision on August 13, 2021, 84 days after receiving the submission on May 21, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K211575 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2021
Decision Date August 13, 2021
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LZG — Pump, Infusion, Insulin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725

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