510(k) K203768 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Omnipod 5 ACE Pump (Pod)
| Applicant | Insulet Corporation, Acton MA, US |
| Decision | Substantially Equivalent, Jan 27, 2022 |
| Received | Dec 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203768
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2023 | Insulet Corporation Omnipod 5 Automated Insulin Delivery System Open, Classified |
QFG | None listed |
| Dec 7, 2022 | Insulet Corporation Omnipod 5 Automated Insulin Delivery System
Product catalog numbers:
PT-000409: ASM, Omnipod 5, PDM, Programmed
PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US
PT-000429: Cable, Charg Open, Classified |
QFG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.