COMPANY
FDA-cleared device company
Location: Acton, MA · source · Oct 15, 2026
Profile checked Oct 10, 2026
Timeline
- FDA FDA 510(k) clearance: Omnipod 6 algorithm — K261461, Jun 29, 2026. Applicant at approval: Insulet Corporation. source ↗
- FDA FDA 510(k) clearance: Omnipod 5 algorithm — K251779, Dec 3, 2025. Applicant at approval: Insulet Corporation. source ↗
FDA records (last 2 years)
- FDA 510(k) clearance: Omnipod 6 algorithm — K261461, Jun 29, 2026. Applicant at approval: Insulet Corporation. source ↗
- FDA 510(k) clearance: Omnipod 5 algorithm — K251779, Dec 3, 2025. Applicant at approval: Insulet Corporation. source ↗