Insulet Corporation
FDA 510(k) & PMA Approved Devices — 19 products
Total Devices19
Categories4
Latest FDA decision2026-06-29
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261461 | Omnipod 6 algorithm | QJI | 2026-06-29 | View |
| 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 |
No matching devices.
Related Clinical Trials
NCT06144554Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 DiabetesRECRUITINGNCT07039942French Prospective Multicentric Study in Real WorldACTIVE_NOT_RECRUITINGNCT07039981Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 DiabetesCOMPLETEDNCT07317102Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)RECRUITINGNCT07521475Evaluation of the Fully Closed Loop Omnipod® System in Type 2 DiabetesRECRUITINGNCT07579702Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 SystemRECRUITINGNCT07593625Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1DRECRUITING