HIB · Class II · 21 CFR 884.4530

FDA Product Code HIB: Speculum, Vaginal, Nonmetal

Leading manufacturers include Welch Allyn, Inc., Zinnanti Surgical Instruments, Inc. and Femspec LLC.

72
Total
72
Cleared
146d
Avg days
1982
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 234d recently vs 145d historically

FDA 510(k) Cleared Speculum, Vaginal, Nonmetal Devices (Product Code HIB)

72 devices
1–24 of 72
Cleared Mar 06, 2026
JFord Speculum Sleeve™
K252208
Ford Medtech, LLC
Obstetrics & Gynecology · 234d
Cleared Apr 28, 2014
BRELLA-SPEC(TM) VAGINAL SPECULUM
K133857
Proa Medical, Inc.
Obstetrics & Gynecology · 130d
Cleared Jan 17, 2014
IOB DISPOSABLE SPECULUM
K132668
Iob Medical, Inc.
Obstetrics & Gynecology · 143d
Cleared Aug 06, 2013
CLEARSPEC SINGLE USE VAGINAL SPECULUM
K130046
Clearspec, LLC
Obstetrics & Gynecology · 210d
Cleared Mar 23, 2012
SPECULUM, VAGINAL, NONMETAL
K120743
Welch Allyn, Inc.
Obstetrics & Gynecology · 11d
Cleared Sep 15, 2011
KOLPLUX SYSTEM
K110766
Kolplast CI Ltda
Obstetrics & Gynecology · 181d
Cleared Feb 16, 2010
NON-STERILE DISPOSABLE VAGINAL SPECULUM
K092870
Kunshan Deyi Plastic Co., Ltd.
Obstetrics & Gynecology · 151d
Cleared Sep 09, 2009
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
K091937
Obp Corporation
Obstetrics & Gynecology · 71d
Cleared Feb 08, 2008
MEDLINE DISPOSABLE VAGINAL SPECULUM
K072942
Medline Industries, Inc.
Obstetrics & Gynecology · 114d
Cleared Jan 22, 2008
DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
K072762
Depalt, Inc.
Obstetrics & Gynecology · 116d
Cleared May 18, 2007
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
K070964
Welch Allyn, Inc.
Obstetrics & Gynecology · 43d
Cleared Sep 19, 2006
HIERSPEC SPECULUM
K061339
Medical Products Div.
Obstetrics & Gynecology · 127d
Cleared May 04, 2006
IGS VAGINAL SPECULUM
K060129
Innovative Gynecological Solutions, LLC
Obstetrics & Gynecology · 106d
Cleared Apr 06, 2006
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
K052420
Gynova, LLC
Obstetrics & Gynecology · 216d
Cleared Feb 02, 2006
FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
K052192
Femspec LLC
Obstetrics & Gynecology · 175d
Cleared Dec 15, 2005
YUSHENG DISPOSABLE VAGINAL SPECULUM
K052912
Zhejiang Yusheng Medical Instrument Co. , Ltd.
Obstetrics & Gynecology · 59d
Cleared Nov 09, 2005
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
K052314
Dynarex Corp.
Obstetrics & Gynecology · 76d
Cleared Jul 11, 2005
GONGDONG DISPOSABLE VAGINAL SPECULUM
K050887
Zhejiang Gongdong Medical Plastic Factory
Obstetrics & Gynecology · 95d
Cleared Dec 23, 2004
FEMSPEC DISPOSABLE VAGINAL SPECULUM
K041757
Femspec LLC
Obstetrics & Gynecology · 177d
Cleared Nov 30, 2004
VAG O SPECULUM, MODELS VS1, VM1, VL1
K042950
Panatrex, Inc.
Obstetrics & Gynecology · 35d
Cleared Jul 12, 2002
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
K021676
Cypress Medical Products, Ltd.
Obstetrics & Gynecology · 52d
Cleared Sep 29, 1999
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
K992736
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 47d
Cleared Sep 01, 1999
PATTON SPECULUM
K991963
Patton Medical Corp.
Obstetrics & Gynecology · 83d
Cleared Jul 19, 1999
GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043
K991827
Ri Mos. S.R.L.
Obstetrics & Gynecology · 52d

About Product Code HIB - Regulatory Context

510(k) Submission Activity

72 total 510(k) submissions under product code HIB since 1982, with 72 receiving FDA clearance (average review time: 146 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - HIB Product Code

Recent submissions under HIB have taken an average of 234 days to reach a decision - up from 145 days historically. Manufacturers should account for longer review timelines in current project planning.

HIB devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →