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Insulet Corporation

FDA 510(k) & PMA Approved Devices — 18 products

Total Devices18
Categories4
Latest Approval2025-12-03
TypeNumberDevice NameCodeDate
510(k) K251779 Omnipod 5 algorithm QJI 2025-12-03 View
510(k) K241777 SmartAdjust™ Technology QJI 2024-08-26 View
510(k) K232741 SmartAdjust(TM) technology QJI 2024-05-29 View
510(k) K231826 Omnipod 5 ACE Pump QFG 2023-10-18 View
510(k) K231824 SmartBolus Calculator QRX 2023-10-18 View
510(k) K223372 Omnipod GO Insulin Delivery Device LZG 2023-04-24 View
510(k) K222239 SmartBolus Calculator QRX 2022-08-19 View
510(k) K220394 SmartAdjust(TM) technology QJI 2022-08-19 View
510(k) K203774 SmartAdjust technology QJI 2022-01-27 View
510(k) K203772 Omnipod 5 SmartBolus Calculator QRX 2022-01-27 View
510(k) K203768 Omnipod 5 ACE Pump (Pod) QFG 2022-01-27 View
510(k) K211575 Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System LZG 2021-08-13 View
510(k) K192659 Omnipod Insulin Management System, Omnipod DASH Insulin Management System LZG 2019-10-21 View
510(k) K191679 Omnipod DASH Insulin Management System with interoperable technology QFG 2019-09-20 View
510(k) K182630 Omnipod Insulin Management System, Omnipod DASH Insulin Management System LZG 2019-01-08 View
510(k) K180045 Omnipod DASH Insulin Management System LZG 2018-06-01 View
510(k) K162296 OmniPod Insulin Management System LZG 2017-04-18 View
510(k) K160252 OmniPod Insulin Management System LZG 2016-04-27 View
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