Omnipod 5 ACE Pump (Pod)— 510(k) K203768

Substantially Equivalent

Insulet Corporation

FDA 510(k) clearance K203768 for Omnipod 5 ACE Pump (Pod), Substantially Equivalent on 2022-01-27. Applicant: Insulet Corporation.

Clearance details

Applicant: Insulet Corporation
Product code: Code QFG
Advisory panel: Clinical Chemistry
Date received: 2020-12-23
Decision date: 2022-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

Download summary PDF View on FDA.gov ↗

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, 2020-01-01 through 2026-04-23. 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.