Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
FDA 510(k) clearance K211575 · decided 2021-08-13
Clearance details
- K-number
- K211575
- Device name
- Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
- Applicant
- Insulet Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-05-21
- Decision date
- 2021-08-13
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- LZG
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Acton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BL recall (Z-2604-2026) | Insulet Corporation | 2026-06-30 |
| Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZX recall (Z-2605-2026) | Insulet Corporation | 2026-06-30 |
| 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM recall (Z-0154-2023) | Insulet Corporation | 2022-11-15 |