Product Code: HDB
FDA class 2
21 CFR 884.4340
Extractor, Vacuum, Fetal
Obstetrics/Gynecology
The Fetal Vacuum Extractor is an obstetrical device comprising a suction cup applied to the fetal scalp and a vacuum pump, used as an alternative to forceps to assist in vaginal delivery by providing controlled traction on the fetal head during uterine contractions. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HDB under regulation 21 CFR 884.4340 in the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
510(k)s
29
FEI Numbers
16
Registration Numbers
16
Unique Applicants
17
Years Active
28
Basic Information
- Product Code
- HDB
- Device Class
- FDA class 2
- Regulation Number
- 884.4340
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 29 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K041579 | MEDELA SINGLE USE SILC CUP, MODEL 077.0791 | Apr 21, 2005 | Substantially Equivalent | MEDELA AG |
| K043614 | VACULINK, MODEL VCL 3000 | Apr 14, 2005 | Substantially Equivalent | MEDEVCO, INC. |
| K021193 | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 | Feb 12, 2003 | Substantially Equivalent | FORTUNE MEDICAL INSTRUMENT CORP. |
| K020447 | MITYVAC MERLIN, MODEL 10027 | Apr 12, 2002 | Substantially Equivalent | PRISM ENTERPRISES, INC. |
| K013460 | SWIFT LOW PROFILE CUP (PRO CUP) | Jan 17, 2002 | Substantially Equivalent | SWIFT DELIVERY PRODUCTS |
| K011532 | MITYVAC | Jul 30, 2001 | Substantially Equivalent | PRISM ENTERPRISES, INC. |
| K981260 | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M | Sep 22, 1998 | Substantially Equivalent | CLINICAL INNOVATIONS, INC. |
| K980976 | AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP | Aug 21, 1998 | Substantially Equivalent | HOLLISTER, INC. |
| K980212 | MITYVAC | Jul 09, 1998 | Substantially Equivalent | PRISM TECHNOLOGIES, INC. |
| K973942 | SWIFT DELIVERY PRODUCT #300 | Dec 12, 1997 | Substantially Equivalent | SWIFT DELIVERY PRODUCTS |
| K970170 | SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE | Mar 28, 1997 | Substantially Equivalent | RICHARD G. LINDSAY |
| K963287 | VACUUM CUP (004SD) | Oct 28, 1996 | Substantially Equivalent | SWIFT DELIVERY PRODUCTS |
| K960549 | MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE | Aug 29, 1996 | Substantially Equivalent | NEWARD ENTERPRISES, INC. |
| K942725 | CMI VELVET TOUCH VACUUM EXTRACTOR | May 05, 1995 | Substantially Equivalent | COLUMBIA MEDICAL & SURGICAL, INC. |
| K943938 | MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE | May 03, 1995 | Substantially Equivalent | NEWARD ENTERPRISES, INC. |
| K934011 | MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE | May 04, 1994 | Substantially Equivalent | NEWARD ENTERPRISES, INC. |
| K913324 | MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT | Jun 22, 1992 | Substantially Equivalent | NEWARD ENTERPRISES, INC. |
| K915763 | MODIFIED DISPOSABLE FETAL VACUUM | Mar 18, 1992 | Substantially Equivalent | COLUMBIA MEDICAL & SURGICAL, INC. |
| K911326 | OBSTETRICAL VACUUM CUP | Aug 14, 1991 | Substantially Equivalent | GESCO INTL., INC. |
| K895700 | AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR | Apr 02, 1990 | Substantially Equivalent | HOLLISTER, INC. |
| K895446 | CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) | Nov 27, 1989 | Substantially Equivalent | CHALLENGE MFG., INC. |
| K891465 | OBSTETRIC CUP (MODIFICATION) | May 11, 1989 | Substantially Equivalent | GO MEDICAL INDUSTRIES PTY. LTD. |
| K890307 | MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE | Mar 31, 1989 | Substantially Equivalent | NEWARD ENTERPRISES, INC. |
| K881967 | CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.) | Jun 13, 1988 | Substantially Equivalent | CHALLENGE MFG., INC. |
| K881306 | CMI VACUUM DELIVERY SYSTEM #003C AND #004C | Jun 13, 1988 | Substantially Equivalent | CHALLENGE MFG., INC. |
| K841492 | AB VACUUM EXTRACTOR SILC-CUP | May 07, 1984 | Substantially Equivalent | MEDELA, INC. |
| K840008 | O'NEIL OBSTETRIC CUP | Apr 25, 1984 | Substantially Equivalent | GOMEDICAL INDUSTRIES PTY LTD. |
| K830012 | MEDELA SUCTION PUMP | Jan 24, 1983 | Substantially Equivalent | MEDELA, INC. |
| K771558 | SILASTIC BRAND OBSTETRICAL VACUUM CUP | Sep 20, 1977 | Substantially Equivalent | DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.