About This 510(k) Submission
K250298 is an FDA 510(k) clearance for the 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), a Extractor, Vacuum, Fetal (Class II — Special Controls, product code HDB), submitted by Clinical Innovations, LLC (Murray, US). The FDA issued a Cleared decision on October 8, 2025, 250 days after receiving the submission on January 31, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4340.