Clearance Summary
SANSA HSAT received FDA 510(k) clearance under submission number K252497, sponsored by Huxley Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2025-12-10.
- Submission: K252497
- Applicant / Sponsor: Huxley Medical
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2375
- Decision date: 2025-12-10
Classification & Regulation
This clearance is catalogued under FDA product code MNR and 21 CFR 868.2375, within the Anesthesiology review panel as a Class II device.