Clearance Summary
Omnipod DASH Insulin Management System with interoperable technology received FDA 510(k) clearance under submission number K191679, sponsored by Insulet Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2019-09-20.
- Submission: K191679
- Applicant / Sponsor: Insulet Corporation
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 880.5730
- Decision date: 2019-09-20
Classification & Regulation
This clearance is catalogued under FDA product code QFG and 21 CFR 880.5730, within the Clinical Chemistry review panel as a Class II device.