Omnipod 5 algorithm— 510(k) K251779

Substantially Equivalent

Insulet Corporation

FDA 510(k) clearance K251779 for Omnipod 5 algorithm, Substantially Equivalent on 2025-12-03. Applicant: Insulet Corporation.

Clearance details

Applicant: Insulet Corporation
Product code: Code QJI
Advisory panel: Clinical Chemistry
Date received: 2025-06-10
Decision date: 2025-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QJI

product code QJI

Other: 3
Total: 3

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.