Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
FDA 510(k) K211575 · Insulet Corporation
510(k) numberK211575
Submission
- Device name
- Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
- Applicant
- Insulet Corporation
Acton, MA, US - Received
- May 21, 2021
- Decision date
- August 13, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZG – Pump, Infusion, Insulin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code LZG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262153 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/02/2026SE |
| K253534 | Pivot Insulin Delivery SystemLZG · Traditional | Modular Medical | 04/08/2026SE |
| K240158 | Modular Medical MODD1 Insulin Delivery SystemLZG · Traditional | Modular Medical, Inc. | 09/04/2024SE |
| K241622 | Extended Reservoir; MiniMed ReservoirLZG · Special | Medtronic Minimed | 07/02/2024SE |
| K223372 | Omnipod GO Insulin Delivery DeviceLZG · Traditional | Insulet Corporation | 04/24/2023SE |
| K210714 | Extended ReservoirLZG · Traditional | Medtronic Minimed, Inc. | 04/06/2022SE |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 10/21/2019SE |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 01/08/2019SE |
| K180045 | Omnipod DASH Insulin Management SystemLZG · Traditional | Insulet Corporation | 06/01/2018SE |
| K162296 | OmniPod Insulin Management SystemLZG · Traditional | Insulet Corporation | 04/18/2017SE |
More from Insulet Corporation
| 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 |
Questions and answers
When was Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System cleared by the FDA?
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (K211575) received a 510(k) decision of Substantially Equivalent on August 13, 2021, 84 days after the submission was received.
What is the product code of K211575?
The FDA product code is LZG – Pump, Infusion, Insulin, a Class II (moderate risk) device regulated under 21 CFR 880.5725.