Insulet Corporation - FDA 510(k) Cleared Devices
23
Total
23
Cleared
0
Denied
FDA 510(k) cleared devices by Insulet Corporation Chemistry ✕
13 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
Cleared
Sep 20, 2019
Omnipod DASH Insulin Management System with interoperable technology
Chemistry
88d