510(k) K231826 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Omnipod 5 ACE Pump
| Applicant | Insulet Corporation, Acton MA, US |
| Decision | Substantially Equivalent, Oct 18, 2023 |
| Received | Jun 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231826
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| Apr 10, 2026 | Insulet Corporation Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 Open, Classified |
QFG | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.