HDBClass II

Extractor, Vacuum, Fetal

21 CFR 884.4340 / Obstetrics/Gynecology

HDB is the FDA product code for Extractor, Vacuum, Fetal, a class II device type, regulated under 21 CFR 884.4340. As of 2026-09-10, FDA records hold 30 510(k) clearances under this code, the most recent dated 2025-10-08, and 6 recalls.

Classification record

Product code: HDB
Device name: Extractor, Vacuum, Fetal
Regulation: 21 CFR 884.4340
Device class: Class II
Review panel: Obstetrics/Gynecology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 30
Ingested recalls: 6

Clearances, product code HDB

By decision year

30 clearances under product code HDB with a decision year between 1977 and 2025, 1989 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code HDB by decision year
Year	Clearances
1977	1
1983	1
1984	2
1988	2
1989	3
1990	1
1991	1
1992	2
1994	1
1995	2
1996	2
1997	2
1998	3
2001	1
2002	2
2003	1
2005	2
2025	1

Applicants with the most clearances

Product code HDB

Applicants holding the most 510(k) clearances under product code HDB
Applicant	Clearances
Neward Enterprises, Inc.	5
Challenge Mfg., Inc.	3
Medela AG	3
Swift Delivery Products	3
Clinical Innovations, LLC	2
Columbia Medical & Surgical, Inc.	2
Go Medical Industries Pty., Ltd.	2
Hollister, Inc.	2
Prism Enterprises, Inc.	2
Dow Corning Corp. Healthcare Industries Materials	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order