Insulet Corporation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Insulet Corporation - FDA 510(k) Cleared Devices
Recent clearances: Omnipod 5 algorithm, SmartAdjust™ Technology, SmartAdjust(TM) technology
23
Total
23
Cleared
0
Denied
Insulet Corporation has 23 FDA 510(k) cleared medical devices. Based in Bedford, US.
Latest FDA clearance: Dec 2025. Active since 2005. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Insulet Corporation Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Insulet Corporation
23 devices
Cleared
Dec 03, 2025
Omnipod 5 algorithm
Chemistry
176d
Cleared
Aug 26, 2024
SmartAdjust™ Technology
Chemistry
67d
Cleared
May 29, 2024
SmartAdjust(TM) technology
Chemistry
265d
Cleared
Oct 18, 2023
SmartBolus Calculator
Chemistry
119d
Cleared
Oct 18, 2023
Omnipod 5 ACE Pump
Chemistry
119d
Cleared
Apr 24, 2023
Omnipod GO Insulin Delivery Device
Chemistry
171d
Cleared
Aug 19, 2022
SmartAdjust(TM) technology
Chemistry
189d
Cleared
Aug 19, 2022
SmartBolus Calculator
Chemistry
24d
Cleared
Jan 27, 2022
Omnipod 5 ACE Pump (Pod)
Chemistry
400d
Cleared
Jan 27, 2022
Omnipod 5 SmartBolus Calculator
Chemistry
400d
Cleared
Jan 27, 2022
SmartAdjust technology
Chemistry
400d
Cleared
Aug 13, 2021
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
Chemistry
84d