510(k) K192659 ยท LZG Pump, Infusion, Insulin
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
| Applicant | Insulet Corporation, Acton MA, US |
| Decision | Substantially Equivalent, Oct 21, 2019 |
| Received | Sep 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192659
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2021 | Insulet Corporation Omnipod DASH Insulin Management System User Guide (OUS Only)
Product Catalog Number:
PT 000002 XXX XXX XX
PT 000318
PT 000319
Distributed to: Canada (French only), the Netherlands, France, Austria, Terminated |
LZG | None listed |
| Apr 2, 2020 | Insulet Corporation Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for t Terminated |
LZG | None listed |
| Apr 2, 2020 | Insulet Corporation Omnipod DASH Insulin Management System (mmol/L
configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for Terminated |
LZG | None listed |
| Feb 13, 2020 | Insulet Corporation Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1
EU: PT-000010 - M/D: INT1-D001-MG
PT-000011 M/D: INT1-D001-MM
UDI 10385082000009
The Om Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.