Cleared Traditional

Omnipod DASH Insulin Management System with interoperable technology

K191679 · Insulet Corporation · Chemistry

Sep 2019

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K191679 is an FDA 510(k) clearance for the Omnipod DASH Insulin Management System with interoperable technology, a Alternate Controller Enabled Insulin Infusion Pump (Class II — Special Controls, product code QFG), submitted by Insulet Corporation (Acton, US). The FDA issued a Cleared decision on September 20, 2019, 88 days after receiving the submission on June 24, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5730.

Submission Details

510(k) Number	K191679 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 2019
Decision Date	September 20, 2019
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QFG — Alternate Controller Enabled Insulin Infusion Pump
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5730
Definition	An Alternate Controller Enabled Insulin Infusion Pump (ace Insulin Pump) Is A Device Intended For The Infusion Of Insulin Into A Patient. The Ace Insulin Pump May Include Basal And Bolus Drug Delivery At Set Or Variable Rates. Ace Insulin Pumps Are Designed To Reliably And Securely Communicate With External Devices, Such As Automated Insulin Dosing Systems, To Allow Insulin Delivery Commands To Be Received, Executed, And Confirmed. Ace Insulin Pumps Are Intended To Be Used Both Alone And In Conjunction With Digitally Connected Medical Devices For The Purpose Of Insulin Delivery.