HDB · Extractor, Vacuum, Fetal
Obstetrics/Gynecology · 21 CFR 884.4340 · Class 2
Overview
| Product Code | HDB |
|---|---|
| Device Name | Extractor, Vacuum, Fetal |
| Regulation | 21 CFR 884.4340 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 30)
Showing 20 most recent of 30 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250298 | 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) | Clinical Innovations, LLC | Oct 8, 2025 | SESE |
| K041579 | MEDELA SINGLE USE SILC CUP, MODEL 077.0791 | Medela AG | Apr 21, 2005 | SESE |
| K043614 | VACULINK, MODEL VCL 3000 | Medevco, Inc. | Apr 14, 2005 | SESE |
| K021193 | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 | Fortune Medical Instrument Corp. | Feb 12, 2003 | SESE |
| K020447 | MITYVAC MERLIN, MODEL 10027 | Prism Enterprises, Inc. | Apr 12, 2002 | SESE |
| K013460 | SWIFT LOW PROFILE CUP (PRO CUP) | Swift Delivery Products | Jan 17, 2002 | SESE |
| K011532 | MITYVAC | Prism Enterprises, Inc. | Jul 30, 2001 | SESE |
| K981260 | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M | Clinical Innovations, Inc. | Sep 22, 1998 | SESE |
| K980976 | AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP | Hollister, Inc. | Aug 21, 1998 | SESE |
| K980212 | MITYVAC | Prism Technologies, Inc. | Jul 9, 1998 | SESE |
| K973942 | SWIFT DELIVERY PRODUCT #300 | Swift Delivery Products | Dec 12, 1997 | SESE |
| K970170 | SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE | Richard G. Lindsay | Mar 28, 1997 | SESE |
| K963287 | VACUUM CUP (004SD) | Swift Delivery Products | Oct 28, 1996 | SESE |
| K960549 | MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | Aug 29, 1996 | SESE |
| K942725 | CMI VELVET TOUCH VACUUM EXTRACTOR | Columbia Medical & Surgical, Inc. | May 5, 1995 | SESE |
| K943938 | MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | May 3, 1995 | SESE |
| K934011 | MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE | Neward Enterprises, Inc. | May 4, 1994 | SESE |
| K913324 | MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT | Neward Enterprises, Inc. | Jun 22, 1992 | SESE |
| K915763 | MODIFIED DISPOSABLE FETAL VACUUM | Columbia Medical & Surgical, Inc. | Mar 18, 1992 | SESE |
| K911326 | OBSTETRICAL VACUUM CUP | Gesco Intl., Inc. | Aug 14, 1991 | SESE |
Top Applicants
- Neward Enterprises, Inc. — 5 clearances
- Swift Delivery Products — 3 clearances
- Challenge Mfg., Inc. — 3 clearances
- Prism Enterprises, Inc. — 2 clearances
- Medela, Inc. — 2 clearances
