Insulet Corporation - FDA 510(k) Cleared Devices

Cleared Dec 03, 2025

Omnipod 5 algorithm

K251779 · QJI

Chemistry · 176d

Cleared Aug 26, 2024

SmartAdjust™ Technology

K241777 · QJI

Chemistry · 67d

Cleared May 29, 2024

SmartAdjust(TM) technology

K232741 · QJI

Chemistry · 265d

Cleared Oct 18, 2023

SmartBolus Calculator

K231824 · QRX

Chemistry · 119d

Cleared Oct 18, 2023

Omnipod 5 ACE Pump

K231826 · QFG

Chemistry · 119d

Cleared Apr 24, 2023

Omnipod GO Insulin Delivery Device

K223372 · LZG

Chemistry · 171d

Cleared Aug 19, 2022

SmartAdjust(TM) technology

K220394 · QJI

Chemistry · 189d

Cleared Aug 19, 2022

SmartBolus Calculator

K222239 · QRX

Chemistry · 24d

Cleared Jan 27, 2022

Omnipod 5 ACE Pump (Pod)

K203768 · QFG

Chemistry · 400d

Cleared Jan 27, 2022

Omnipod 5 SmartBolus Calculator

K203772 · QRX

Chemistry · 400d

Cleared Jan 27, 2022

SmartAdjust technology

K203774 · QJI

Chemistry · 400d

Cleared Aug 13, 2021

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

K211575 · LZG

Chemistry · 84d