Medical Device Manufacturer · US , Bedford , MA

Insulet Corporation

23 submissions · 23 cleared · Since 2005
23
Total
23
Cleared
0
Denied

Insulet Corporation — FDA 510(k) Submissions

Insulet Corporation has submitted 23 FDA 510(k) premarket notifications since 2005, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Pump, Infusion, Insulin, Interoperable Automated Glycemic Controller, Continuous Glucose Monitor Informed Insulin Dose Calculator, Alternate Controller Enabled Insulin Infusion Pump . Use the specialty filter in the sidebar to narrow results.

23 devices
1–23 of 23
Omnipod 5 algorithm
K251779 · QJI Interoperable Automated... · Chemistry
Dec 2025 176d
SmartAdjust? Technology
K241777 · QJI Interoperable Automated... · Chemistry
Aug 2024 67d
SmartAdjust(TM) technology
K232741 · QJI Interoperable Automated... · Chemistry
May 2024 265d
SmartBolus Calculator
K231824 · QRX Continuous Glucose... · Chemistry
Oct 2023 119d
Omnipod 5 ACE Pump
K231826 · QFG Alternate Controller... · Chemistry
Oct 2023 119d
Omnipod GO Insulin Delivery Device
K223372 · LZG Pump, Infusion, Insulin · Chemistry
Apr 2023 171d
SmartAdjust(TM) technology
K220394 · QJI Interoperable Automated... · Chemistry
Aug 2022 189d
SmartBolus Calculator
K222239 · QRX Continuous Glucose... · Chemistry
Aug 2022 24d
Omnipod 5 ACE Pump (Pod)
K203768 · QFG Alternate Controller... · Chemistry
Jan 2022 400d
Omnipod 5 SmartBolus Calculator
K203772 · QRX Continuous Glucose... · Chemistry
Jan 2022 400d
SmartAdjust technology
K203774 · QJI Interoperable Automated... · Chemistry
Jan 2022 400d
Omnipod? Insulin Management System, Omnipod DASH? Insulin Management System
K211575 · LZG Pump, Infusion, Insulin · Chemistry
Aug 2021 84d
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K192659 · LZG Pump, Infusion, Insulin · General Hospital
Oct 2019 26d
Omnipod DASH Insulin Management System with interoperable technology
K191679 · QFG Alternate Controller... · Chemistry
Sep 2019 88d
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K182630 · LZG Pump, Infusion, Insulin · General Hospital
Jan 2019 106d
Omnipod DASH Insulin Management System
K180045 · LZG Pump, Infusion, Insulin · General Hospital
Jun 2018 144d
OmniPod Insulin Management System
K162296 · LZG Pump, Infusion, Insulin · General Hospital
Apr 2017 245d
OmniPod Insulin Management System
K160252 · LZG Pump, Infusion, Insulin · General Hospital
Apr 2016 86d
OMNIPOD INSULIN MANAGEMENT SYSTEM
K140439 · LZG Pump, Infusion, Insulin · General Hospital
Nov 2014 265d
OMNIPOD INSULIN MANAGEMENT SYSTEM
K131294 · LZG Pump, Infusion, Insulin · General Hospital
Aug 2013 115d
OMNIPOD INSULIN MANAGMENT SYSTEM
K122953 · LZG Pump, Infusion, Insulin · General Hospital
Dec 2012 73d
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
K111669 · LZG Pump, Infusion, Insulin · General Hospital
Dec 2011 183d
IXL-II DIABETES MANAGEMENT SYSTEM
K042792 · LZG Pump, Infusion, Insulin · General Hospital
Jan 2005 89d
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