Cleared Traditional

Ultra-Fast Vitri; Ultra-Fast Warm

K251305 · Kitazato Corporation · Obstetrics & Gynecology
Aug 2025
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K251305 is an FDA 510(k) clearance for the Ultra-Fast Vitri; Ultra-Fast Warm, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Kitazato Corporation (Fuji-City, JP). The FDA issued a Cleared decision on August 26, 2025, 120 days after receiving the submission on April 28, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K251305 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2025
Decision Date August 26, 2025
Days to Decision 120 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQL — Media, Reproductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6180

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