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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractor, Vacuum, Fetal
510(k) Number K250298
Device Name Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S)
Applicant
Clinical Innovations, LLC
747 W 4170 S
Murray,  UT  84123
Applicant Contact Alexis Ross
Correspondent
Clinical Innovations, LLC
747 W 4170 S
Murray,  UT  84123
Correspondent Contact Alexis Ross
Regulation Number884.4340
Classification Product Code
HDB  
Date Received01/31/2025
Decision Date 10/08/2025
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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