Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System

Pump, Infusion, Insulin

Insulet Corporation

The following data is part of a premarket notification filed by Insulet Corporation with the FDA for Omnipod® Insulin Management System, Omnipod Dash® Insulin Management System.

Pre-market Notification Details

• Device ID: K211575
• 510k Number: K211575
• Device Name: Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
• Classification: Pump, Infusion, Insulin
• Applicant: Insulet Corporation 100 Nagog Park Acton, MA 01720
• Contact: Dennis Shay
• Correspondent: Dennis Shay; Insulet Corporation 100 Nagog Park Acton, MA 01720
• Product Code: LZG
• Subsequent Product Code: NBW
• Subsequent Product Code: NDC
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-05-21
• Decision Date: 2021-08-13