Omnipod 5 ACE Pump— 510(k) K231826
Substantially EquivalentInsulet Corporation
FDA 510(k) clearance K231826 for Omnipod 5 ACE Pump, Substantially Equivalent on 2023-10-18. Applicant: Insulet Corporation.
Clearance details
- Applicant
- Insulet Corporation
- Product code
- Code QFG
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Acton, MA, US
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.