Cleared Traditional

K122953 - OMNIPOD INSULIN MANAGMENT SYSTEM (FDA 510(k) Clearance)

K122953 · Insulet Corporation · General Hospital
Dec 2012
Decision
73d
Days
Class 2
Risk

K122953 is an FDA 510(k) clearance for the OMNIPOD INSULIN MANAGMENT SYSTEM. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).

Submitted by Insulet Corporation (Bedford, US). The FDA issued a Cleared decision on December 7, 2012, 73 days after receiving the submission on September 25, 2012.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K122953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2012
Decision Date December 07, 2012
Days to Decision 73 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