Cleared Traditional

Omnipod Insulin Management System, Omnipod DASH Insulin Management System

K192659 · Insulet Corporation · General Hospital

Oct 2019

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K192659 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 (Acton, US). The FDA issued a Cleared decision on October 21, 2019, 26 days after receiving the submission on September 25, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K192659 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 2019
Decision Date	October 21, 2019
Days to Decision	26 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF