Company · US
Insulet Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (2 in 12 months)
21recalls (4 in 12 months)
21recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 29, 2026 | K261461 | Omnipod 6 algorithm Insulet Corporation | QJI |
| Dec 3, 2025 | K251779 | Omnipod 5 algorithm Insulet Corporation | QJI |
| Aug 26, 2024 | K241777 | SmartAdjust Technology Insulet Corporation | QJI |
| May 29, 2024 | K232741 | SmartAdjust(TM) technology Insulet Corporation | QJI |
| Oct 18, 2023 | K231826 | Omnipod 5 ACE Pump Insulet Corporation | QFG |
| Oct 18, 2023 | K231824 | SmartBolus Calculator Insulet Corporation | QRX |
| Apr 24, 2023 | K223372 | Omnipod GO Insulin Delivery Device Insulet Corporation | LZG |
| Aug 19, 2022 | K222239 | SmartBolus Calculator Insulet Corporation | QRX |
| Aug 19, 2022 | K220394 | SmartAdjust(TM) technology Insulet Corporation | QJI |
| Jan 27, 2022 | K203774 | SmartAdjust technology Insulet Corporation | QJI |
| Jan 27, 2022 | K203772 | Omnipod 5 SmartBolus Calculator Insulet Corporation | QRX |
| Jan 27, 2022 | K203768 | Omnipod 5 ACE Pump (Pod) Insulet Corporation | QFG |
| Aug 13, 2021 | K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System Insulet Corporation | LZG |
| Oct 21, 2019 | K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System Insulet Corporation | LZG |
| Sep 20, 2019 | K191679 | Omnipod DASH Insulin Management System with interoperable technology Insulet Corporation | QFG |
| Jan 8, 2019 | K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System Insulet Corporation | LZG |
| Jun 1, 2018 | K180045 | Omnipod DASH Insulin Management System Insulet Corporation | LZG |
| Apr 18, 2017 | K162296 | OmniPod Insulin Management System Insulet Corporation | LZG |
| Apr 27, 2016 | K160252 | OmniPod Insulin Management System Insulet Corporation | LZG |
| Nov 13, 2014 | K140439 | OMNIPOD INSULIN MANAGEMENT SYSTEM Insulet Corporation | LZG |
| Aug 29, 2013 | K131294 | OMNIPOD INSULIN MANAGEMENT SYSTEM Insulet Corporation | LZG |
| Dec 7, 2012 | K122953 | OMNIPOD INSULIN MANAGMENT SYSTEM Insulet Corporation | LZG |
| Dec 15, 2011 | K111669 | FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS Insulet Corporation | LZG |
| Jan 3, 2005 | K042792 | IXL-II DIABETES MANAGEMENT SYSTEM Insulet Corporation | LZG |
| Dec 19, 2003 | K031373 | IXL DIABETES MANAGEMENT SYSTEM Insulet Corp. | LZG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2026 | Insulet Corporation Omnipod (Eros) Pod. Includes the below Model/REF Numbers:
1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod).
2. ZXR425 (10-Pack), ZXR420 (Single Pod).
3. ZXP425 (10 Pack), ZXP420 (Single Pod). Open, Classified |
LZG | K211575 |
| Jun 30, 2026 | Insulet Corporation Omnipod DASH Pod. Includes the below Model/REF Numbers:
1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod).
2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod).
3. BLE-I1-529 (10-Pack) Open, Classified |
LZG | K211575 |
| Jun 30, 2026 | Insulet Corporation 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. BL Open, Classified |
QFG | K231826 |
| Apr 10, 2026 | Insulet Corporation Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 Open, Classified |
QFG | K231826 |
| Oct 10, 2025 | Insulet Corporation 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 simultaneous Open, Classified |
QRX | K231826 |
| Jun 24, 2025 | Insulet Corporation 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
Open, Classified |
QRX | K231826 |
| Jan 4, 2024 | Insulet Corporation 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 Open, Classified |
QFG | K231826 |
| Sep 20, 2023 | Insulet Corporation Omnipod 5 Automated Insulin Delivery System Open, Classified |
QFG | K203768 |
| Dec 7, 2022 | Insulet Corporation 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, Charg Open, Classified |
QFG | K203768 |
| Nov 15, 2022 | Insulet Corporation 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 C Terminated |
LZG | K211575 |
| Feb 1, 2021 | Insulet Corporation 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, Terminated |
LZG | K192659 |
| Apr 2, 2020 | Insulet Corporation Omnipod DASH Insulin Management System (mmol/L
configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for Terminated |
LZG | K192659 |
| Apr 2, 2020 | Insulet Corporation 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 t Terminated |
LZG | K192659 |
| Feb 13, 2020 | Insulet Corporation 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 Om Terminated |
LZG | K192659 |
| Dec 18, 2018 | Insulet Corporation Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1 Terminated |
LZG | K180045 |
| Dec 15, 2015 | Insulet Corporation OmniPod, Insulin Management System (OUS)
Catalog Number: 14810
Product Usage:
The OmnniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for th Terminated |
LZG | K122953 |
| Dec 15, 2015 | Insulet Corporation OmniPod, Insulin Management System (US)
Catalog Number: PODZXP420
Product Usage:
The OmnniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for Terminated |
LZG | K122953 |
| Sep 4, 2015 | Insulet Corporation OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of Terminated |
LZG | K122953 |
| Sep 4, 2015 | Insulet Corporation OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management Terminated |
LZG | K122953 |
| Nov 5, 2013 | Insulet Corporation OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490)
Product Usage:
The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by heal Terminated |
LZG | K122953 |
| Nov 5, 2013 | Insulet Corporation OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit)
Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Ins Terminated |
LZG | K122953 |