Clearance Summary
CaRi-Heart received FDA 510(k) clearance under submission number DEN250042, sponsored by Caristo Diagnostics , Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-07-28.
- Submission: DEN250042
- Applicant / Sponsor: Caristo Diagnostics , Ltd.
- Clearance pathway: Direct
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2215
- Decision date: 2026-07-28
Classification & Regulation
This clearance is catalogued under FDA product code SIU and 21 CFR 870.2215, within the Cardiovascular review panel as a Class II device.