Data / Medical devices / United States / Insulet Corporation
Insulet Corporation: FDA-registered device maker in Acton, MA, United States, 7 510(k) clearances
Insulet Corporation is registered with the FDA (registration 3014585508) in Acton, MA, United States. It lists 10 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 3, 2025. 11 recall events name it as the recalling firm (4 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014585508
- Address
- 100 Nagog Park, Acton, MA, United States, 01720
- Owner or operator
- INSULET CORPORATION (9056196)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- January 31, 2012
- Registered through
- 2026
- Brand names listed
- Amgen Adhesive Overlay, Omnipod, Omnipod 5 Algorithm, Omnipod 5 Pod, Omnipod 5 SmartAdjust, Omnipod DASH, Omnipod Dash, Omnipod Discover and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alternate Controller Enabled Insulin Infusion Pump | QFG | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Calculator, Drug Dose | NDC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Continuous Glucose Monitor Informed Insulin Dose Calculator | QRX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Continuous Glucose Monitor Retrospective Data Analysis Software | PHV | 1 | Manufacturer | accessdata.fda.gov |
| Injector, Pen | NSC | 2 | Contract manufacturer | accessdata.fda.gov |
| Interoperable Automated Glycemic Controller | QJI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Introducer, Syringe Needle | KZH | 2 | Contract manufacturer | accessdata.fda.gov |
| Pump, Infusion, Insulin | LZG | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 3, 2025 | K251779 | Omnipod 5 algorithm | QJI | Substantially Equivalent | Insulet Corporation | accessdata.fda.gov |
| August 26, 2024 | K241777 | SmartAdjust Technology | QJI | Substantially Equivalent | Insulet Corporation | accessdata.fda.gov |
| October 18, 2023 | K231826 | Omnipod 5 ACE Pump | QFG | Substantially Equivalent | Insulet Corporation | accessdata.fda.gov |
| October 18, 2023 | K231824 | SmartBolus Calculator | QRX | Substantially Equivalent | Insulet Corporation | accessdata.fda.gov |
| April 24, 2023 | K223372 | Omnipod GO Insulin Delivery Device | LZG | Substantially Equivalent | Insulet Corporation | accessdata.fda.gov |
| August 13, 2021 | K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | LZG | Substantially Equivalent | Insulet Corporation | accessdata.fda.gov |
| September 20, 2019 | K191679 | Omnipod DASH Insulin Management System with interoperable technology | QFG | Substantially Equivalent | Insulet Corporation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 20, 2026 | 99034 | Class I | Ongoing | Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 | External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to u | accessdata.fda.gov |
| March 12, 2026 | 98586 | Class I | Ongoing | Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 | Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised | accessdata.fda.gov |
| September 11, 2025 | 97597 | Class II | Ongoing | The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a singl | The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples | accessdata.fda.gov |
| May 23, 2025 | 96945 | Class II | Ongoing | Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app st | Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that fo | accessdata.fda.gov |
| November 30, 2023 | 93511 | Class I | Ongoing | Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (pro | The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus. | accessdata.fda.gov |
| February 28, 2023 | 92909 | Class II | Ongoing | Omnipod 5 Automated Insulin Delivery System | An error message was received when using the Omnipod 5 App on compatible smartphones that prevented control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which may cause a delay in therapy. To reduce the volume of inquiries Insulet was receiving from customers, an was sent to all control users and the cause o | accessdata.fda.gov |
| November 14, 2022 | 91127 | Class II | Ongoing | Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Hori | The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The excess heat may cause minor burns if touched, and the Omnipod 5 Controller may fail to charge, requiring the user to switch t | accessdata.fda.gov |
| October 17, 2022 | 90987 | Class I | Terminated | 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Dia | The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM. | accessdata.fda.gov |
| February 1, 2021 | 87305 | Class II | Terminated | Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Gree | Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the User Guide, the text states that the comma (,) is not used for the decimal on the PDM, when in fact it is the period (.) that is not used.If a user were to use the | accessdata.fda.gov |
| April 2, 2020 | 85552 | Class II | Terminated | Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diab | After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount. | accessdata.fda.gov |
| February 13, 2020 | 84982 | Class II | Terminated | Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manag | In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may lead to hypoglycemia or hyperglycemia. | accessdata.fda.gov |
Compare with other makers
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- All makers of Calculator, Drug Dose
Updated June 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.