HDFClass I

Speculum, Vaginal, Metal

21 CFR 884.4520 / Obstetrics/Gynecology

HDF is the FDA product code for Speculum, Vaginal, Metal, a class I device type, regulated under 21 CFR 884.4520. As of 2026-09-10, FDA records hold 11 510(k) clearances under this code, the most recent dated 1994-02-28, and 3 recalls.

Classification record

Product code: HDF
Device name: Speculum, Vaginal, Metal
Regulation: 21 CFR 884.4520
Device class: Class I
Review panel: Obstetrics/Gynecology
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 11
Ingested recalls: 3

Clearances, product code HDF

By decision year

11 clearances under product code HDF with a decision year between 1982 and 1994, 1989 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code HDF by decision year
Year	Clearances
1982	2
1984	1
1985	2
1986	1
1989	3
1990	1
1994	1

Applicants with the most clearances

Product code HDF

Applicants holding the most 510(k) clearances under product code HDF
Applicant	Clearances
Conphar, Inc.	2
Downs Surgical, Ltd.	2
Zinnanti Surgical Instruments, Inc.	2
Artiberia	1
Franklin Medical USA, Inc.	1
Gynescope Corp.	1
Kinetic Medical Products	1
Thomasville Medical Assoc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 219 companies shown, in name order