510(k) K251305

Ultra-Fast Vitri; Ultra-Fast Warm by Kitazato Corporation — Product Code MQL

K251305 is an FDA 510(k) premarket notification submitted by Kitazato Corporation for the device "Ultra-Fast Vitri; Ultra-Fast Warm". The FDA issued a decision of Substantially Equivalent on August 26, 2025. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Kitazato Corporation has at least 10 other 510(k) clearances on record.