510(k) K211575 · LZG Pump, Infusion, Insulin
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
| Applicant | Insulet Corporation, Acton MA, US |
| Decision | Substantially Equivalent, Aug 13, 2021 |
| Received | May 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211575
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2026 | Insulet Corporation Omnipod DASH Pod. Includes the below Model/REF Numbers:
1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod).
2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod).
3. BLE-I1-529 (10-Pack) Open, Classified |
LZG | None listed |
| Jun 30, 2026 | Insulet Corporation Omnipod (Eros) Pod. Includes the below Model/REF Numbers:
1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod).
2. ZXR425 (10-Pack), ZXR420 (Single Pod).
3. ZXP425 (10 Pack), ZXP420 (Single Pod). Open, Classified |
LZG | None listed |
| Nov 15, 2022 | Insulet Corporation 18239: ASM Omnipod Dash PDM, insulin delivery system.
PT-000010: Assembly, Dash Final PDM U100, mg/dL
PT-000011: Assembly, Dash Final PDM U100, mmol/L
PT-000030: Assembly, DASH PDM, Canada
Remote C Terminated |
LZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.