Clearance Summary
SmartSpectra Vital Signs Monitor 1.0 received FDA 510(k) clearance under submission number K254169, sponsored by Presage Security, Inc. d/b/a Presage Technologies, 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 2026-06-18.
- Submission: K254169
- Applicant / Sponsor: Presage Security, Inc. d/b/a Presage Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2785
- Decision date: 2026-06-18
Classification & Regulation
This clearance is catalogued under FDA product code QME and 21 CFR 870.2785, within the Cardiovascular review panel as a Class II device.