Cleared Traditional

OmniPod Insulin Management System

K162296 · Insulet Corporation · General Hospital
Apr 2017
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K162296 is an FDA 510(k) clearance for the OmniPod 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 April 18, 2017, 245 days after receiving the submission on August 16, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K162296 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2016
Decision Date April 18, 2017
Days to Decision 245 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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