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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Reproductive
510(k) Number K251305
Device Name Ultra-Fast Vitri; Ultra-Fast Warm
Applicant
Kitazato Corporation
100-10 Yanagishima
Fuji,  JP 416-0932
Applicant Contact Kyoko Izumi
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd.
Bldg. 1, Suite 300
Austin,  TX  78746
Correspondent Contact Mei Li
Regulation Number884.6180
Classification Product Code
MQL  
Date Received04/28/2025
Decision Date 08/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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