K251779
- 510(k) number
- K251779
- Device name
- Omnipod 5 algorithm
- Applicant
- Insulet Corporation MA · US
- Product code
- QJI — Interoperable Automated Glycemic Controller
- Decision date
- 2025-12-03
- Date received
- 2025-06-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251779.pdf
Official FDA record: K251779
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.