Insulet Corporation
Medical device manufacturer in Acton, MA.
25510(k) clearances
0PMA approvals
21recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261461 | Omnipod 6 algorithmQJI · Traditional | 06/29/2026SE |
| K251779 | Omnipod 5 algorithmQJI · Traditional | 12/03/2025SE |
| K241777 | SmartAdjust TechnologyQJI · Traditional | 08/26/2024SE |
| K232741 | SmartAdjust(TM) technologyQJI · Traditional | 05/29/2024SE |
| K231826 | Omnipod 5 ACE PumpQFG · Traditional | 10/18/2023SE |
| K231824 | SmartBolus CalculatorQRX · Traditional | 10/18/2023SE |
| K223372 | Omnipod GO Insulin Delivery DeviceLZG · Traditional | 04/24/2023SE |
| K222239 | SmartBolus CalculatorQRX · Traditional | 08/19/2022SE |
| K220394 | SmartAdjust(TM) technologyQJI · Traditional | 08/19/2022SE |
| K203774 | SmartAdjust technologyQJI · Traditional | 01/27/2022SE |
| K203772 | Omnipod 5 SmartBolus CalculatorQRX · Traditional | 01/27/2022SE |
| K203768 | Omnipod 5 ACE Pump (Pod)QFG · Traditional | 01/27/2022SE |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemLZG · Traditional | 08/13/2021SE |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | 10/21/2019SE |
| K191679 | Omnipod DASH Insulin Management System with interoperable technologyQFG · Traditional | 09/20/2019SE |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | 01/08/2019SE |
| K180045 | Omnipod DASH Insulin Management SystemLZG · Traditional | 06/01/2018SE |
| K162296 | OmniPod Insulin Management SystemLZG · Traditional | 04/18/2017SE |
| K160252 | OmniPod Insulin Management SystemLZG · Traditional | 04/27/2016SE |
| K140439 | Omnipod Insulin Management SystemLZG · Traditional | 11/13/2014SE |
| K131294 | Omnipod Insulin Management SystemLZG · Traditional | 08/29/2013SE |
| K122953 | Omnipod Insulin Managment SystemLZG · Traditional | 12/07/2012SE |
| K111669 | Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management SystemsLZG · Traditional | 12/15/2011SE |
| K042792 | Ixl-Ii Diabetes Management SystemLZG · Traditional | 01/03/2005SE |
| K031373 | Ixl Diabetes Management SystemLZG · Traditional | 12/19/2003SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2605-2026 Class I | Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD-…External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of… | 05/20/2026Open, Classified |
| Z-2604-2026 Class I | Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack)…External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of… | 05/20/2026Open, Classified |
| Z-2603-2026 Class I | Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2.…External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of… | 05/20/2026Open, Classified |
| Z-1797-2026 Class I | Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that… | 03/12/2026Open, Classified |
| Z-0132-2026 Class II | The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on…The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry… | 09/11/2025Open, Classified |
| Z-2016-2025 Class II | Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number:…Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not… | 05/23/2025Open, Classified |
| Z-0591-2024 Class I | Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3…The bolus calculator is not recording the decimal point if it is the first value entered when changing a… | 11/30/2023Open, Classified |
| Z-2618-2023 Class II | Omnipod 5 Automated Insulin Delivery SystemAn error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone… | 02/28/2023Open, Classified |
| Z-0423-2023 Class II | Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM…The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and… | 11/14/2022Open, Classified |
| Z-0154-2023 Class I | 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final…The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery… | 10/17/2022Terminated |
| Z-1203-2021 Class II | Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT…Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and… | 02/01/2021Terminated |
| Z-2165-2020 Class II | Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011…After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the… | 04/02/2020Terminated |
| Z-2164-2020 Class II | Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010…After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the… | 04/02/2020Terminated |
| Z-1553-2020 Class II | Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D:…In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose… | 02/13/2020Terminated |
| Z-0347-2020 Class II | Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001…There is a potential for a communication interruption following a bolus command that may result in… | 12/18/2018Terminated |
| Z-0394-2016 Class I | OmniPod, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The…Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. | 11/02/2015Terminated |
| Z-0393-2016 Class I | OmniPod, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The…Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. | 11/02/2015Terminated |
| Z-2485-2015 Class I | OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog…OmniPods (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be… | 07/13/2015Terminated |
| Z-2484-2015 Class I | OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog…OmniPods (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be… | 07/13/2015Terminated |
| Z-0166-2014 Class II | OmniPod Insulin Management Product Demonstration Kit; Model Reference Number:…Alcohol Prep Pads contained within the kit are not properly labeled. | 09/27/2013Terminated |
| Z-0165-2014 Class II | OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400…Alcohol Prep Pads contained within the kit are not properly labeled. | 09/27/2013Terminated |