Cleared Traditional

K203768 - Omnipod 5 ACE Pump (Pod) (FDA 510(k) Clearance)

K203768 · Insulet Corporation · Chemistry device

Jan 2022

Decision

400d

Days

Class 2

Risk

K203768 is an FDA 510(k) clearance for the Omnipod 5 ACE Pump (Pod). This device is classified as 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 January 27, 2022, 400 days after receiving the submission on December 23, 2020.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 880.5730. 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..

Submission Details

510(k) Number	K203768 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 23, 2020
Decision Date	January 27, 2022
Days to Decision	400 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.