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Insulet Corporation

24 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Omnipod 6 algorithm (K261461)Insulet Corporation2026-06-29
Omnipod 5 algorithm (K251779)Insulet Corporation2025-12-03
SmartAdjust™ Technology (K241777)Insulet Corporation2024-08-26
SmartAdjust(TM) technology (K232741)Insulet Corporation2024-05-29
SmartBolus Calculator (K231824)Insulet Corporation2023-10-18
Omnipod 5 ACE Pump (K231826)Insulet Corporation2023-10-18
Omnipod GO Insulin Delivery Device (K223372)Insulet Corporation2023-04-24
SmartAdjust(TM) technology (K220394)Insulet Corporation2022-08-19
SmartBolus Calculator (K222239)Insulet Corporation2022-08-19
SmartAdjust technology (K203774)Insulet Corporation2022-01-27
Omnipod 5 ACE Pump (Pod) (K203768)Insulet Corporation2022-01-27
Omnipod 5 SmartBolus Calculator (K203772)Insulet Corporation2022-01-27
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (K211575)Insulet Corporation2021-08-13
Omnipod Insulin Management System, Omnipod DASH Insulin Management System (K192659)Insulet Corporation2019-10-21
Omnipod DASH Insulin Management System with interoperable technology (K191679)Insulet Corporation2019-09-20
Omnipod Insulin Management System, Omnipod DASH Insulin Management System (K182630)Insulet Corporation2019-01-08
Omnipod DASH Insulin Management System (K180045)Insulet Corporation2018-06-01
OmniPod Insulin Management System (K162296)Insulet Corporation2017-04-18
OmniPod Insulin Management System (K160252)Insulet Corporation2016-04-27
OMNIPOD INSULIN MANAGEMENT SYSTEM (K140439)Insulet Corporation2014-11-13
OMNIPOD INSULIN MANAGEMENT SYSTEM (K131294)Insulet Corporation2013-08-29
OMNIPOD INSULIN MANAGMENT SYSTEM (K122953)Insulet Corporation2012-12-07
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS (K111669)Insulet Corporation2011-12-15
IXL-II DIABETES MANAGEMENT SYSTEM (K042792)Insulet Corporation2005-01-03

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Every clearance here is in the API, with alerts when new ones post.