Cleared Traditional

Omnipod DASH Insulin Management System

K180045 · Insulet Corporation · General Hospital
Jun 2018
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K180045 is an FDA 510(k) clearance for the Omnipod DASH Insulin Management System, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Insulet Corporation (Billerica, US). The FDA issued a Cleared decision on June 1, 2018, 144 days after receiving the submission on January 8, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K180045 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2018
Decision Date June 01, 2018
Days to Decision 144 days
Submission Type Traditional
Review Panel General Hospital (HO)
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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