Clearance Summary
Vital Signs Monitor (CLEO2) received FDA 510(k) clearance under submission number K260438, sponsored by Infinium Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2026-08-14.
- Submission: K260438
- Applicant / Sponsor: Infinium Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2026-08-14
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.