Atlas FDA

HDB

30 FDA 510(k) clearances · Product code

105 daysmedian time to decision
311 days90th percentile
30clearances measured

FDA profile

Official device name
Extractor, Vacuum, Fetal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4340
Medical specialty
Obstetrics/Gynecology
Flags
Third-party review eligible
Adverse events (MAUDE)
2020: 24 · 2021: 21 · 2023: 23 · 2024: 24 · 2025: 17 · 2026: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
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) (K250298)Clinical Innovations, LLC2025-10-08
MEDELA SINGLE USE SILC CUP, MODEL 077.0791 (K041579)Medela AG2005-04-21
VACULINK, MODEL VCL 3000 (K043614)Medevco, Inc.2005-04-14
FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 (K021193)Fortune Medical Instrument Corp.2003-02-12
MITYVAC MERLIN, MODEL 10027 (K020447)Prism Enterprises, Inc.2002-04-12
SWIFT LOW PROFILE CUP (PRO CUP) (K013460)Swift Delivery Products2002-01-17
MITYVAC (K011532)Prism Enterprises, Inc.2001-07-30
KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M (K981260)Clinical Innovations, Inc.1998-09-22
AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP (K980976)Hollister, Inc.1998-08-21
MITYVAC (K980212)Prism Technologies, Inc.1998-07-09
SWIFT DELIVERY PRODUCT #300 (K973942)Swift Delivery Products1997-12-12
SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE (K970170)Richard G. Lindsay1997-03-28
VACUUM CUP (004SD) (K963287)Swift Delivery Products1996-10-28
MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE (K960549)Neward Enterprises, Inc.1996-08-29
CMI VELVET TOUCH VACUUM EXTRACTOR (K942725)Columbia Medical & Surgical, Inc.1995-05-05
MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE (K943938)Neward Enterprises, Inc.1995-05-03
MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE (K934011)Neward Enterprises, Inc.1994-05-04
MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT (K913324)Neward Enterprises, Inc.1992-06-22
MODIFIED DISPOSABLE FETAL VACUUM (K915763)Columbia Medical & Surgical, Inc.1992-03-18
OBSTETRICAL VACUUM CUP (K911326)Gesco Intl., Inc.1991-08-14
AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR (K895700)Hollister, Inc.1990-04-02
CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) (K895446)Challenge Mfg., Inc.1989-11-27
OBSTETRIC CUP (MODIFICATION) (K891465)Go Medical Industries Pty. , Ltd.1989-05-11
MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE (K890307)Neward Enterprises, Inc.1989-03-31
CMI VACUUM DELIVERY SYSTEM #003C AND #004C (K881306)Challenge Mfg., Inc.1988-06-13
CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.) (K881967)Challenge Mfg., Inc.1988-06-13
AB VACUUM EXTRACTOR SILC-CUP (K841492)Medela, Inc.1984-05-07
O'NEIL OBSTETRIC CUP (K840008)Go Medical Industries Pty. , Ltd.1984-04-25
MEDELA SUCTION PUMP (K830012)Medela, Inc.1983-01-24
SILASTIC BRAND OBSTETRICAL VACUUM CUP (K771558)Dow Corning Corp. Healthcare Industries Materials1977-09-20

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Every clearance here is in the API, with alerts when new ones post.