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Insulet Corporation: 510(k) Clearances

25 510(k) clearances from Dec 19, 2003 to Jun 29, 2026, newest first. Showing 1 to 25.

What this list covers: FDA records filed under the name "Insulet Corporation" and its spelling variant "Insulet".

Back to the Insulet Corporation profile

K-NumberDeviceDate
K261461Omnipod 6 algorithmJun 29, 2026
K251779Omnipod 5 algorithmDec 3, 2025
K241777SmartAdjust™ TechnologyAug 26, 2024
K232741SmartAdjust(TM) technologyMay 29, 2024
K231826Omnipod 5 ACE PumpOct 18, 2023
K231824SmartBolus CalculatorOct 18, 2023
K223372Omnipod GO Insulin Delivery DeviceApr 24, 2023
K222239SmartBolus CalculatorAug 19, 2022
K220394SmartAdjust(TM) technologyAug 19, 2022
K203774SmartAdjust technologyJan 27, 2022
K203772Omnipod 5 SmartBolus CalculatorJan 27, 2022
K203768Omnipod 5 ACE Pump (Pod)Jan 27, 2022
K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemAug 13, 2021
K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemOct 21, 2019
K191679Omnipod DASH Insulin Management System with interoperable technologySep 20, 2019
K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemJan 8, 2019
K180045Omnipod DASH Insulin Management SystemJun 1, 2018
K162296OmniPod Insulin Management SystemApr 18, 2017
K160252OmniPod Insulin Management SystemApr 27, 2016
K140439OMNIPOD INSULIN MANAGEMENT SYSTEMNov 13, 2014
K131294OMNIPOD INSULIN MANAGEMENT SYSTEMAug 29, 2013
K122953OMNIPOD INSULIN MANAGMENT SYSTEMDec 7, 2012
K111669FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMSDec 15, 2011
K042792IXL-II DIABETES MANAGEMENT SYSTEMJan 3, 2005
K031373IXL DIABETES MANAGEMENT SYSTEMDec 19, 2003

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.