Cleared Traditional

Omnipod Insulin Management System, Omnipod DASH Insulin Management System

K182630 · Insulet Corporation · General Hospital

Jan 2019

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K182630 is an FDA 510(k) clearance for the Omnipod Insulin Management System, 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 January 8, 2019, 106 days after receiving the submission on September 24, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K182630 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2018
Decision Date	January 08, 2019
Days to Decision	106 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF