HDB · Class II · 21 CFR 884.4340

FDA Product Code HDB: Extractor, Vacuum, Fetal

Leading manufacturers include Medela, Inc., Hollister, Inc. and Swift Delivery Products.

30
Total
30
Cleared
141d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 250d recently vs 137d historically

FDA 510(k) Cleared Extractor, Vacuum, Fetal Devices (Product Code HDB)

30 devices
1–24 of 30
Cleared Oct 08, 2025
Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M)
K250298
Clinical Innovations, LLC
Obstetrics & Gynecology · 250d
Cleared Apr 21, 2005
MEDELA SINGLE USE SILC CUP, MODEL 077.0791
K041579
Medela AG
Obstetrics & Gynecology · 311d
Cleared Apr 14, 2005
VACULINK, MODEL VCL 3000
K043614
Medevco, Inc.
Obstetrics & Gynecology · 105d
Cleared Sep 22, 1998
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M
K981260
Clinical Innovations, Inc.
Obstetrics & Gynecology · 169d
Cleared Aug 21, 1998
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP
K980976
Hollister, Inc.
Obstetrics & Gynecology · 158d
Cleared Jul 09, 1998
MITYVAC
K980212
Prism Technologies, Inc.
Obstetrics & Gynecology · 169d
Cleared Dec 12, 1997
SWIFT DELIVERY PRODUCT #300
K973942
Swift Delivery Products
Obstetrics & Gynecology · 77d
Cleared Mar 28, 1997
SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE
K970170
Richard G. Lindsay
Obstetrics & Gynecology · 78d
Cleared Oct 28, 1996
VACUUM CUP (004SD)
K963287
Swift Delivery Products
Obstetrics & Gynecology · 68d
Cleared Aug 29, 1996
MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE
K960549
Neward Enterprises, Inc.
Obstetrics & Gynecology · 203d
Cleared Aug 14, 1991
OBSTETRICAL VACUUM CUP
K911326
Gesco Intl., Inc.
Obstetrics & Gynecology · 141d
Cleared Apr 02, 1990
AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR
K895700
Hollister, Inc.
Obstetrics & Gynecology · 192d
Cleared May 07, 1984
AB VACUUM EXTRACTOR SILC-CUP
K841492
Medela, Inc.
Obstetrics & Gynecology · 27d
Cleared Jan 24, 1983
MEDELA SUCTION PUMP
K830012
Medela, Inc.
Obstetrics & Gynecology · 21d
Cleared Sep 20, 1977
SILASTIC BRAND OBSTETRICAL VACUUM CUP
K771558
Dow Corning Corp. Healthcare Industries Materials
Obstetrics & Gynecology · 36d

About Product Code HDB - Regulatory Context

510(k) Submission Activity

30 total 510(k) submissions under product code HDB since 1977, with 30 receiving FDA clearance (average review time: 141 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - HDB Product Code

Recent submissions under HDB have taken an average of 250 days to reach a decision - up from 137 days historically. Manufacturers should account for longer review timelines in current project planning.

HDB devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →