Omnipod 5 ACE Pump (Pod)— 510(k) K203768
Substantially EquivalentInsulet Corporation
FDA 510(k) clearance K203768 for Omnipod 5 ACE Pump (Pod), Substantially Equivalent on 2022-01-27. Applicant: Insulet Corporation. Device class: 2.
Clearance details
- Applicant
- Insulet Corporation
- Product code
- Code QFG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5730
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Acton, MA, US
Recent devices under product code QFG
view allMore clearances from Insulet Corporation
view allAdverse events under product code QFG
product code QFG- Death
- 228
- Injury
- 118,915
- Malfunction
- 1,001,752
- Other
- 7
- Total
- 1,120,902
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 K203768
K-number listed on FDA's recall record- Z-2618-2023 — Omnipod 5 Automated Insulin Delivery System
- Z-0423-2023 — 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, Charging, Omnipod 5, Horizon PDM
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203768.
Data sourced from openFDA. This site is unofficial and independent of the FDA.