Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M) +3 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K250298

Identifiers

510(k) Number: K250298 FDA 510(k)
FDA Product Code: HDB FDA 510(k)
Models / Variants: Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M) FDA 510(k)EUDAMED
Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT) FDA 510(k)EUDAMED
Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C) FDA 510(k)EUDAMED
Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 884.4340 FDA 510(k)
Regulation Number: 884.4340 FDA 510(k)
Advisory Committee: Obstetrics/Gynecology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Kiwi Complete Vacuum Delivery System is a fetal vacuum extractor designed for assisted vaginal delivery. It includes multiple cup variants—OmniCup, OmniCup with Traction Force Indicator, OmniC Cup for Cesarean Section, and ProCup—each tailored for specific obstetric applications. This device facilitates controlled extraction of the fetus during labor by applying negative pressure via a vacuum cup system, reducing maternal trauma and improving delivery outcomes. It adheres to the FDA’s classification as a Class II medical device under the product code HDB for fetal vacuum extractors.

The system is supplied as a reusable, non-sterile kit requiring terminal sterilization prior to use in clinical settings. Each variant (VAC-DUAL M, VAC-DUAL MT, VAC-DUAL C, VAC-DUAL S) is MRI-safe and designed for single-patient use per manufacturer guidelines. Storage instructions specify protection from moisture and extreme temperatures, with regulatory compliance confirmed under FDA 510(k) clearance (K250298), EU Medical Device Directive (MDD), and EU Medical Device Regulation (MDR). Authorized for obstetrics/gynecology applications, it is listed under OpenFDA’s fetal vacuum extractor category (registration numbers included).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K250298	Class II	Active

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Manufacturer

Manufacturer: Clinical Innovations, LLC

Sources (2)

FDA 510(k) K250298 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026