Omnipod 5 ACE Pump (Pod)
FDA 510(k) clearance K203768 · decided 2022-01-27
Clearance details
- K-number
- K203768
- Device name
- Omnipod 5 ACE Pump (Pod)
- Applicant
- Insulet Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-12-23
- Decision date
- 2022-01-27
- Days to decision
- 400 days
- Clearance type
- Traditional
- Product code
- QFG
- Device class
- 2
- Regulation number
- 880.5730
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Acton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Omnipod 5 Automated Insulin Delivery System recall (Z-2618-2023) | Insulet Corporation | 2023-09-20 |
| Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnip recall (Z-0423-2023) | Insulet Corporation | 2022-12-07 |