Omnipod 5 ACE Pump
FDA 510(k) clearance K231826 · decided 2023-10-18
Clearance details
- K-number
- K231826
- Device name
- Omnipod 5 ACE Pump
- Applicant
- Insulet Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-06-21
- Decision date
- 2023-10-18
- Days to decision
- 119 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 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1- recall (Z-2603-2026) | Insulet Corporation | 2026-06-30 |
| Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 recall (Z-1797-2026) | Insulet Corporation | 2026-04-10 |
| The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a recall (Z-0132-2026) | Insulet Corporation | 2025-10-10 |
| Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009 recall (Z-2016-2025) | Insulet Corporation | 2025-06-24 |
| Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current) recall (Z-0591-2024) | Insulet Corporation | 2024-01-04 |