FDA 510(k) Applications Submitted by Insulet Corporation

FDA 510(k) Number Submission Date Device Name Applicant
K042792 10/06/2004 IXL-II DIABETES MANAGEMENT SYSTEM INSULET CORPORATION
K220394 02/11/2022 SmartAdjust(TM) technology Insulet Corporation
K222239 07/26/2022 SmartBolus Calculator Insulet Corporation
K203768 12/23/2020 Omnipod 5 ACE Pump (Pod) Insulet Corporation
K203774 12/23/2020 SmartAdjust technology Insulet Corporation
K140439 02/21/2014 OMNIPOD INSULIN MANAGEMENT SYSTEM INSULET CORPORATION
K211575 05/21/2021 Omnipod« Insulin Management System, Omnipod DASH« Insulin Management System Insulet Corporation
K191679 06/24/2019 Omnipod DASH Insulin Management System with interoperable technology Insulet Corporation
K182630 09/24/2018 Omnipod Insulin Management System, Omnipod DASH Insulin Management System Insulet Corporation
K192659 09/25/2019 Omnipod Insulin Management System, Omnipod DASH Insulin Management System Insulet Corporation
K203772 12/23/2020 Omnipod 5 SmartBolus Calculator Insulet Corporation
K223372 11/04/2022 Omnipod GO Insulin Delivery Device Insulet Corporation
K180045 01/08/2018 Omnipod DASH Insulin Management System Insulet Corporation
K160252 02/01/2016 OmniPod Insulin Management System INSULET CORPORATION
K162296 08/16/2016 OmniPod Insulin Management System INSULET CORPORATION
K122953 09/25/2012 OMNIPOD INSULIN MANAGMENT SYSTEM INSULET CORPORATION
K111669 06/15/2011 FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS INSULET CORPORATION
K131294 05/06/2013 OMNIPOD INSULIN MANAGEMENT SYSTEM INSULET CORPORATION


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