FDA.reportPublic FDA data

510(k) K250298

Device
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® Comp
Applicant
Clinical Innovations, LLC
510(k) number
K250298
Product code
HDB
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-08
Date received
2025-01-31
Regulation
884.4340
Classification name
Extractor, Vacuum, Fetal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alexis Ross
Address
747 W 4170 S Murray UT US 84123 84123

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HDB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K041579MEDELA SINGLE USE SILC CUP, MODEL 077.0791Medela AG2005-04-21
K043614VACULINK, MODEL VCL 3000Medevco, Inc.2005-04-14
K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300Fortune Medical Instrument Corp.2003-02-12
K020447MITYVAC MERLIN, MODEL 10027Prism Enterprises, Inc.2002-04-12
K013460SWIFT LOW PROFILE CUP (PRO CUP)Swift Delivery Products2002-01-17
K011532MITYVACPrism Enterprises, Inc.2001-07-30
K981260KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000MClinical Innovations, Inc.1998-09-22
K980976AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAPHollister, Inc.1998-08-21
K980212MITYVACPrism Technologies, Inc.1998-07-09
K973942SWIFT DELIVERY PRODUCT #300Swift Delivery Products1997-12-12
K970170SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVERichard G. Lindsay1997-03-28
K963287VACUUM CUP (004SD)Swift Delivery Products1996-10-28
K960549MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLENeward Enterprises, Inc.1996-08-29
K942725CMI VELVET TOUCH VACUUM EXTRACTORColumbia Medical & Surgical, Inc.1995-05-05
K943938MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLENeward Enterprises, Inc.1995-05-03