Atlas FDA

HIB

72 FDA 510(k) clearances · Product code

84 daysmedian time to decision
241 days90th percentile
72clearances measured

FDA profile

Official device name
Speculum, Vaginal, Nonmetal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4530
Medical specialty
Obstetrics/Gynecology
Adverse events (MAUDE)
2006: 3 · 2010: 10 · 2011: 15 · 2012: 15 · 2013: 9 · 2014: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
JFord Speculum Sleeve™ (K252208)Ford Medtech, LLC2026-03-06
BRELLA-SPEC(TM) VAGINAL SPECULUM (K133857)Proa Medical, Inc.2014-04-28
IOB DISPOSABLE SPECULUM (K132668)Iob Medical, Inc.2014-01-17
CLEARSPEC SINGLE USE VAGINAL SPECULUM (K130046)Clearspec, LLC2013-08-06
SPECULUM, VAGINAL, NONMETAL (K120743)Welch Allyn, Inc.2012-03-23
KOLPLUX SYSTEM (K110766)Kolplast CI Ltda2011-09-15
NON-STERILE DISPOSABLE VAGINAL SPECULUM (K092870)Kunshan Deyi Plastic Co., Ltd.2010-02-16
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM (K091937)Obp Corporation2009-09-09
MEDLINE DISPOSABLE VAGINAL SPECULUM (K072942)Medline Industries, Inc.2008-02-08
DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM (K072762)Depalt, Inc.2008-01-22
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM (K070964)Welch Allyn, Inc.2007-05-18
HIERSPEC SPECULUM (K061339)Medical Products Div.2006-09-19
IGS VAGINAL SPECULUM (K060129)Innovative Gynecological Solutions, LLC2006-05-04
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM (K052420)Gynova, LLC2006-04-06
FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I (K052192)Femspec LLC2006-02-02
YUSHENG DISPOSABLE VAGINAL SPECULUM (K052912)Zhejiang Yusheng Medical Instrument Co. , Ltd.2005-12-15
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE (K052314)Dynarex Corp.2005-11-09
GONGDONG DISPOSABLE VAGINAL SPECULUM (K050887)Zhejiang Gongdong Medical Plastic Factory2005-07-11
FEMSPEC DISPOSABLE VAGINAL SPECULUM (K041757)Femspec LLC2004-12-23
VAG O SPECULUM, MODELS VS1, VM1, VL1 (K042950)Panatrex, Inc.2004-11-30
POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM (K040817)Advanced Urological Developments2004-06-22
KENTEX DISPOSABLE VAGINAL SPECULUM (K030693)Kentron Health Care, Inc.2003-08-27
KAISHOU VAGINAL SPECULUM (K030761)Jiangsu Kaishou Medical Apparatus Co., Ltd.2003-06-09
VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L (K022948)Medical Action Industries, Inc.2002-11-04
TAGG DISPOSABLE VAGINAL SPECULUM (K021849)Tagg Industries2002-07-16
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL (K021676)Cypress Medical Products, Ltd.2002-07-12
LEESPEC DISPOSABLE VAGINAL SPECULUM (K021017)Itl Corporation Pty, Ltd.2002-06-19
GLO-SPEC I, II AND III (K020959)Sol Weiss MD, Inc.2002-06-19
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE (K020726)Dukal Corp.2002-05-15
DRG DISPOSABLE VAGINAL SPECULUM (K012535)Doctor'S Research Group, Inc.2002-03-01
GLOBAL HEALTHCARE VAGINAL SPECULUM (K013835)Dynascend Consulting Int'L, LLC2002-01-17
GLO-SPEC (K013817)Sol Weiss MD, Inc.2001-12-21
NU-SPEC D (K012859)Sol Weiss MD, Inc.2001-10-26
VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 (K002912)Sterinc2001-02-21
(DISPOSABLE) VAGINAL SPECULUM (K003540)Feminica, Inc.2001-02-09
MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM (K000444)Prism Enterprises, Inc.2000-04-21
MEDISUL DISPOSABLE VAGINAL SPECULUM (K000414)Marketing Perspectives2000-04-04
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM (K992736)Wallach Surgical Devices, Inc.1999-09-29
PATTON SPECULUM (K991963)Patton Medical Corp.1999-09-01
GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043 (K991827)Ri Mos. S.R.L.1999-07-19
MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303 (K984211)Medscand AB1998-12-23
VITALCARE DISPOSABLE VAGINAL SPECULUM (K983716)Vitalcare Group, Inc.1998-12-23
KOLPLAST VAGINAL SPECULUM (K973853)Kolplast Comercial E Industrial Ltda1997-12-19
HOSPITAL'S SPEC (K974228)Gps1997-12-12
PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS (K971979)Playtex Products, Inc.1997-09-26
NYLON COATED SPECULA (K925501)Zinnanti Surgical Instruments, Inc.1997-06-13
EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC (K963377)North Eos Industries, Inc.1996-10-04
VERSA-VU (K951898)CooperSurgical, Inc.1995-12-11
AMSINO DISPOSABLE VIGINAL SPECULUM (K951528)Amsino Intl., Inc.1995-05-11
KLEENSPEC (K941272)Welch Allyn, Inc.1994-08-02
THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV (K930954)Cabot Medical Corp.1994-06-30
INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION (K922154)Olsen Electrosurgical, Inc.1994-04-21
GRAVESPEC (K935636)Adept-Med Intl., Inc.1994-03-25
SPECULUM (K933521)Bioteque America, Inc.1994-03-07
DISPOSABLE PLASTIC VAGINAL SPECULA (K926536)Thomasville Medical Assoc.1994-02-25
HSG TRAY (K920803)Unimar, Inc.1992-10-19
DISPOSABLE PLASTIC VAGINAL SPECULUM (K903080)Dawnex Industries, Inc.1990-09-19
PHYSICIAN'S CHOICE (K903744)Advance Medical Device, Inc.1990-09-12
DISPOSABLE PLASTIC VAGINAL SPECULA (K894957)Zinnanti Surgical Instruments, Inc.1989-10-12
GYNECOLOGIC EXAMINATION KIT (K894489)A & A Medical, Inc.1989-10-05
AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH MEDIUM #3 (K880587)C.I.S.A. Import Export C/O Larson and Taylor1988-12-20
AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2 (K880586)C.I.S.A. Import Export C/O Larson and Taylor1988-12-20
AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4 (K880588)C.I.S.A. Import Export C/O Larson and Taylor1988-12-20
EURO-MED CLEAR-VUE DISPOSABLE VAGINAL SPECULUM (K882605)Buckman Co., Inc.1988-09-15
MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM (K863274)Martin Medical1986-09-02
MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM (K863275)Martin Medical1986-09-02
HOSPITAL'S-SPEC (K842014)Merex Co.1984-08-17
VAGINAL SPECULUM - DISPOSABLE (K841909)Galenica Enterprises, Inc.1984-07-31
KIDD VAGINAL SPECULUM (K841867)Paul H. Schneider Ent.1984-07-13
GENT-L-SPEC DISPOS. VAGINAL SPECULUM (K830725)Geneva Laboratories, Inc.1983-04-27
DIA-SPEC (K822086)Exitec, Inc.1982-11-08
PRO-SPEC (K822084)Exitec, Inc.1982-08-19

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Every clearance here is in the API, with alerts when new ones post.