Product code HDB
- Device name
- Extractor, Vacuum, Fetal
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.4340
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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... | Clinical Innovations, LLC | 2025-10-08 |
| K041579 | MEDELA SINGLE USE SILC CUP, MODEL 077.0791 | Medela AG | 2005-04-21 |
| K043614 | VACULINK, MODEL VCL 3000 | Medevco, Inc. | 2005-04-14 |
| K021193 | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 | Fortune Medical Instrument Corp. | 2003-02-12 |
| K020447 | MITYVAC MERLIN, MODEL 10027 | Prism Enterprises, Inc. | 2002-04-12 |
| K013460 | SWIFT LOW PROFILE CUP (PRO CUP) | Swift Delivery Products | 2002-01-17 |
| K011532 | MITYVAC | Prism Enterprises, Inc. | 2001-07-30 |
| K981260 | KIWI SOFT CUP WITH PALM PUMP MODEL NUMBER VFE-6000S, KIWI MUSHROOM CUP WITH PALM PUMP MODEL VFE-6000M | Clinical Innovations, Inc. | 1998-09-22 |
| K980976 | AMEDA DISPOSABLE VACUUM ASSIST CUP WITH FLUID RETENTION TRAP | Hollister, Inc. | 1998-08-21 |
| K980212 | MITYVAC | Prism Technologies, Inc. | 1998-07-09 |
| K973942 | SWIFT DELIVERY PRODUCT #300 | Swift Delivery Products | 1997-12-12 |
| K970170 | SWIFT DELIVERY PRODUCT #002-VAC EX CUP W/VAC REL VALVE | Richard G. Lindsay | 1997-03-28 |
| K963287 | VACUUM CUP (004SD) | Swift Delivery Products | 1996-10-28 |
| K960549 | MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | 1996-08-29 |
| K942725 | CMI VELVET TOUCH VACUUM EXTRACTOR | Columbia Medical & Surgical, Inc. | 1995-05-05 |
| K943938 | MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | 1995-05-03 |
| K934011 | MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE | Neward Enterprises, Inc. | 1994-05-04 |
| K913324 | MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT | Neward Enterprises, Inc. | 1992-06-22 |
| K915763 | MODIFIED DISPOSABLE FETAL VACUUM | Columbia Medical & Surgical, Inc. | 1992-03-18 |
| K911326 | OBSTETRICAL VACUUM CUP | Gesco Intl., Inc. | 1991-08-14 |
| K895700 | AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR | Hollister, Inc. | 1990-04-02 |
| K895446 | CMI VACUUM PUMP W/#101A VACUUM PUMP (AUTO-CLAVE.) | Challenge Mfg., Inc. | 1989-11-27 |
| K891465 | OBSTETRIC CUP (MODIFICATION) | Go Medical Industries Pty. , Ltd. | 1989-05-11 |
| K890307 | MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE | Neward Enterprises, Inc. | 1989-03-31 |
| K881306 | CMI VACUUM DELIVERY SYSTEM #003C AND #004C | Challenge Mfg., Inc. | 1988-06-13 |
| K881967 | CMI VACUUM PUMP #001C - VACUUM PUMP (NON-ELECTRI.) | Challenge Mfg., Inc. | 1988-06-13 |
| K841492 | AB VACUUM EXTRACTOR SILC-CUP | Medela, Inc. | 1984-05-07 |
| K840008 | O'NEIL OBSTETRIC CUP | Go Medical Industries Pty. , Ltd. | 1984-04-25 |
| K830012 | MEDELA SUCTION PUMP | Medela, Inc. | 1983-01-24 |
| K771558 | SILASTIC BRAND OBSTETRICAL VACUUM CUP | Dow Corning Corp. Healthcare Industries Materials | 1977-09-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07612367000109 | Silicone tubing ID 6.5mm, 180cm, 1 coupling piece | Medela AG | 2024-05-31 |
| 07612367003902 | Tubing holder right side | Medela AG | 2024-05-31 |
| 07612367003896 | Tubing holder left side | Medela AG | 2024-05-31 |
| 07612367003742 | Safety Set for railholder | Medela AG | 2024-05-31 |
| 07612367003735 | Reusable serial connector | Medela AG | 2024-05-31 |
| 07612367003698 | Overflow protection device | Medela AG | 2024-05-31 |
| 07612367003568 | Quiver 480mm | Medela AG | 2024-05-31 |
| 07612367003551 | Quiver 280mm | Medela AG | 2024-05-31 |
| 07612367003681 | Clip for Lid | Medela AG | 2021-08-12 |
| 07612367003582 | Disposable Specimen Cup | Medela AG | 2016-12-05 |
| 07612367002677 | Suction jar polysulfone 0.25l | Medela AG | 2016-10-24 |
| 07612367002820 | Small lid with conical patient connection and overflow protection device | Medela AG | 2016-10-24 |
| 07612367002684 | Suction jar polysulfone, 0.5l | Medela AG | 2016-10-24 |
| 07612367002691 | Suction Jar Polysulfone, 1l | Medela AG | 2016-10-24 |
| 07612367002707 | Suction jar polysulfone 2l | Medela AG | 2016-10-24 |
| 07612367002714 | Suction jar polysulfone 3l | Medela AG | 2016-10-24 |
| 07612367002721 | Suction jar polysulfone 5l | Medela AG | 2016-10-24 |
| 07612367002806 | Large lid with conical patient connection 6–10 mm | Medela AG | 2016-10-24 |
| 07612367002813 | Large lid with conical patient connection 10–14 mm | Medela AG | 2016-10-24 |
| 07612367002837 | Lid for safety Set with overflow protection device | Medela AG | 2016-10-24 |
| 07612367003957 | Disposable overflow protection / bacteria filter | Medela AG | 2016-10-03 |
| 07612367004138 | Safety device plugged into pump | Medela AG | 2016-10-03 |
| 07612367004152 | Disposable overflow protection / bacteria filter | Medela AG | 2016-10-03 |
| 07612367004169 | Disposable bacteria filter | Medela AG | 2016-10-03 |
| 07612367004183 | Disposable bacteria / odour filter | Medela AG | 2016-10-03 |
| 07612367004237 | Silicone tubing | Medela AG | 2016-10-03 |
| 07612367004244 | Silicone tubing | Medela AG | 2016-10-03 |
| 07612367004251 | Silicone tubing | Medela AG | 2016-10-03 |
| 07612367004268 | Silicone tubing | Medela AG | 2016-10-03 |
| 07612367003599 | Change-over valve with clampholder and tubing set | Medela AG | 2016-09-24 |