Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System— 510(k) K211575
Substantially EquivalentInsulet Corporation
FDA 510(k) clearance K211575 for Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System, Substantially Equivalent on 2021-08-13. Applicant: Insulet Corporation. Device class: 2.
Clearance details
- Applicant
- Insulet Corporation
- Product code
- Code LZG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Acton, MA, US
Recent devices under product code LZG
view allMore clearances from Insulet Corporation
view allAdverse events under product code LZG
product code LZG- Death
- 104
- Injury
- 12,022
- Malfunction
- 135,004
- Other
- 1
- Total
- 147,131
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K211575
K-number listed on FDA's recall record- Z-2604-2026 — 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), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod).
- Z-2605-2026 — 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).
- Z-0154-2023 — 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 Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be incorporated into higher level assemblies such as DASH Starter Kits.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211575.
Data sourced from openFDA. This site is unofficial and independent of the FDA.