Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart E — Obstetrical and Gynecological Surgical Devices](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices) → [21 CFR 884.4340](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4340) → HDB — Extractor, Vacuum, Fetal # HDB · Extractor, Vacuum, Fetal _Obstetrics/Gynecology · 21 CFR 884.4340 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB ## Overview - **Product Code:** HDB - **Device Name:** Extractor, Vacuum, Fetal - **Regulation:** [21 CFR 884.4340](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/884.4340) - **Device Class:** 2 - **Review Panel:** [Obstetrics/Gynecology](/submissions/OB) - **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](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K250298.md) | 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](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K041579.md) | MEDELA SINGLE USE SILC CUP, MODEL 077.0791 | Medela AG | Apr 21, 2005 | SESE | | [K043614](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K043614.md) | VACULINK, MODEL VCL 3000 | Medevco, Inc. | Apr 14, 2005 | SESE | | [K021193](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K021193.md) | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 | Fortune Medical Instrument Corp. | Feb 12, 2003 | SESE | | [K020447](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K020447.md) | MITYVAC MERLIN, MODEL 10027 | Prism Enterprises, Inc. | Apr 12, 2002 | SESE | | [K013460](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K013460.md) | SWIFT LOW PROFILE CUP (PRO CUP) | Swift Delivery Products | Jan 17, 2002 | SESE | | [K011532](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K011532.md) | MITYVAC | Prism Enterprises, Inc. | Jul 30, 2001 | SESE | | [K981260](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K981260.md) | 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](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K980976.md) | AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP | Hollister, Inc. | Aug 21, 1998 | SESE | | [K980212](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K980212.md) | MITYVAC | Prism Technologies, Inc. | Jul 9, 1998 | SESE | | [K973942](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K973942.md) | SWIFT DELIVERY PRODUCT #300 | Swift Delivery Products | Dec 12, 1997 | SESE | | [K970170](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K970170.md) | SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE | Richard G. Lindsay | Mar 28, 1997 | SESE | | [K963287](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K963287.md) | VACUUM CUP (004SD) | Swift Delivery Products | Oct 28, 1996 | SESE | | [K960549](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K960549.md) | MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | Aug 29, 1996 | SESE | | [K942725](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K942725.md) | CMI VELVET TOUCH VACUUM EXTRACTOR | Columbia Medical & Surgical, Inc. | May 5, 1995 | SESE | | [K943938](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K943938.md) | MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | May 3, 1995 | SESE | | [K934011](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K934011.md) | MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE | Neward Enterprises, Inc. | May 4, 1994 | SESE | | [K913324](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K913324.md) | MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT | Neward Enterprises, Inc. | Jun 22, 1992 | SESE | | [K915763](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K915763.md) | MODIFIED DISPOSABLE FETAL VACUUM | Columbia Medical & Surgical, Inc. | Mar 18, 1992 | SESE | | [K911326](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB/K911326.md) | OBSTETRICAL VACUUM CUP | Gesco Intl., Inc. | Aug 14, 1991 | SESE | ## Top Applicants - Neward Enterprises, Inc. — 5 clearances - Challenge Mfg., Inc. — 3 clearances - Swift Delivery Products — 3 clearances - Columbia Medical & Surgical, Inc. — 2 clearances - Go Medical Industries Pty. , Ltd. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HDB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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