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HDB — Extractor, Vacuum, Fetal Class II

FDA Device Classification

Classification Details

Product Code
HDB
Device Class
Class II
Regulation Number
884.4340
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250298clinical innovationsKiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete VacOctober 8, 2025
K041579medelaMEDELA SINGLE USE SILC CUP, MODEL 077.0791April 21, 2005
K043614medevcoVACULINK, MODEL VCL 3000April 14, 2005
K021193fortune medical instrumentFORTUNE SILICONE VACUUM SUCTION, MODEL #1300February 12, 2003
K020447prism enterprisesMITYVAC MERLIN, MODEL 10027April 12, 2002
K013460swift delivery productsSWIFT LOW PROFILE CUP (PRO CUP)January 17, 2002
K011532prism enterprisesMITYVACJuly 30, 2001
K981260clinical innovationsKIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALMSeptember 22, 1998
K980976hollisterAMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAPAugust 21, 1998
K980212prism technologiesMITYVACJuly 9, 1998
K973942swift delivery productsSWIFT DELIVERY PRODUCT #300December 12, 1997
K970170richard g. lindsaySWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVEMarch 28, 1997
K963287swift delivery productsVACUUM CUP (004SD)October 28, 1996
K960549neward enterprisesMITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLEAugust 29, 1996
K942725columbia medical and surgicalCMI VELVET TOUCH VACUUM EXTRACTORMay 5, 1995
K943938neward enterprisesMITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLEMay 3, 1995
K934011neward enterprisesMITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASEMay 4, 1994
K913324neward enterprisesMITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KITJune 22, 1992
K915763columbia medical and surgicalMODIFIED DISPOSABLE FETAL VACUUMMarch 18, 1992
K911326gesco intlOBSTETRICAL VACUUM CUPAugust 14, 1991