Clearance Summary
Ultra-Fast Vitri; Ultra-Fast Warm received FDA 510(k) clearance under submission number K251305, sponsored by Kitazato Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2025-08-26.
- Submission: K251305
- Applicant / Sponsor: Kitazato Corporation
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2025-08-26
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.