Medical Device Manufacturer · US , Bedford , MA

Insulet Corporation - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2005
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
1-23 of 23
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
Cleared Oct 21, 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K192659 · LZG
General Hospital · 26d
Cleared Sep 20, 2019
Omnipod DASH Insulin Management System with interoperable technology
K191679 · QFG
Chemistry · 88d
Cleared Jan 08, 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K182630 · LZG
General Hospital · 106d
Cleared Jun 01, 2018
Omnipod DASH Insulin Management System
K180045 · LZG
General Hospital · 144d
Cleared Apr 18, 2017
OmniPod Insulin Management System
K162296 · LZG
General Hospital · 245d
Cleared Apr 27, 2016
OmniPod Insulin Management System
K160252 · LZG
General Hospital · 86d
Cleared Nov 13, 2014
OMNIPOD INSULIN MANAGEMENT SYSTEM
K140439 · LZG
General Hospital · 265d
Cleared Aug 29, 2013
OMNIPOD INSULIN MANAGEMENT SYSTEM
K131294 · LZG
General Hospital · 115d
Cleared Dec 07, 2012
OMNIPOD INSULIN MANAGMENT SYSTEM
K122953 · LZG
General Hospital · 73d
Cleared Dec 15, 2011
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
K111669 · LZG
General Hospital · 183d
Cleared Jan 03, 2005
IXL-II DIABETES MANAGEMENT SYSTEM
K042792 · LZG
General Hospital · 89d
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