Cleared Traditional

OMNIPOD INSULIN MANAGEMENT SYSTEM

K131294 · Insulet Corporation · General Hospital
Aug 2013
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K131294 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 (Bedford, US). The FDA issued a Cleared decision on August 29, 2013, 115 days after receiving the submission on May 6, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K131294 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2013
Decision Date August 29, 2013
Days to Decision 115 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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