Cleared Traditional

OMNIPOD INSULIN MANAGEMENT SYSTEM

K140439 · Insulet Corporation · General Hospital
Nov 2014
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K140439 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 November 13, 2014, 265 days after receiving the submission on February 21, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K140439 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2014
Decision Date November 13, 2014
Days to Decision 265 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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