Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HIB · Predicate Candidate Screening
72 FDA 510(k) clearances under this product code; the 50 most recent screened below.
84 daysmedian FDA review time
241 days90th percentile
72clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252208 | JFord Speculum Sleeve™ | Ford Medtech, LLC | 2026-03-06 | 234 | 0 |
| K133857 | BRELLA-SPEC(TM) VAGINAL SPECULUM | Proa Medical, Inc. | 2014-04-28 | 130 | 0 |
| K132668 | IOB DISPOSABLE SPECULUM | Iob Medical, Inc. | 2014-01-17 | 143 | 0 |
| K130046 | CLEARSPEC SINGLE USE VAGINAL SPECULUM | Clearspec, LLC | 2013-08-06 | 210 | 0 |
| K120743 | SPECULUM, VAGINAL, NONMETAL | Welch Allyn, Inc. | 2012-03-23 | 11 | 1 |
| K110766 | KOLPLUX SYSTEM | Kolplast CI Ltda | 2011-09-15 | 181 | 0 |
| K092870 | NON-STERILE DISPOSABLE VAGINAL SPECULUM | Kunshan Deyi Plastic Co., Ltd. | 2010-02-16 | 151 | 0 |
| K091937 | OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM | Obp Corporation | 2009-09-09 | 71 | 1 |
| K072942 | MEDLINE DISPOSABLE VAGINAL SPECULUM | Medline Industries, Inc. | 2008-02-08 | 114 | 0 |
| K072762 | DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM | Depalt, Inc. | 2008-01-22 | 116 | 0 |
| K070964 | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLES | Welch Allyn, Inc. | 2007-05-18 | 43 | 0 |
| K061339 | HIERSPEC SPECULUM | Medical Products Div. | 2006-09-19 | 127 | 0 |
| K060129 | IGS VAGINAL SPECULUM | Innovative Gynecological Solutions, LLC | 2006-05-04 | 106 | 0 |
| K052420 | G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM | Gynova, LLC | 2006-04-06 | 216 | 0 |
| K052192 | FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I | Femspec LLC | 2006-02-02 | 175 | 0 |
| K052912 | YUSHENG DISPOSABLE VAGINAL SPECULUM | Zhejiang Yusheng Medical Instrument Co. , Ltd. | 2005-12-15 | 59 | 0 |
| K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM | Dynarex Corp. | 2005-11-09 | 76 | 0 |
| K050887 | GONGDONG DISPOSABLE VAGINAL SPECULUM | Zhejiang Gongdong Medical Plastic Factory | 2005-07-11 | 95 | 0 |
| K041757 | FEMSPEC DISPOSABLE VAGINAL SPECULUM | Femspec LLC | 2004-12-23 | 177 | 0 |
| K042950 | VAG O SPECULUM, MODELS VS1, VM1, VL1 | Panatrex, Inc. | 2004-11-30 | 35 | 0 |
| K040817 | POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM | Advanced Urological Developments | 2004-06-22 | 84 | 0 |
| K030693 | KENTEX DISPOSABLE VAGINAL SPECULUM | Kentron Health Care, Inc. | 2003-08-27 | 175 | 0 |
| K030761 | KAISHOU VAGINAL SPECULUM | Jiangsu Kaishou Medical Apparatus Co., Ltd. | 2003-06-09 | 90 | 0 |
| K022948 | VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L | Medical Action Industries, Inc. | 2002-11-04 | 60 | 0 |
| K021849 | TAGG DISPOSABLE VAGINAL SPECULUM | Tagg Industries | 2002-07-16 | 41 | 0 |
| K021676 | CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NO | Cypress Medical Products, Ltd. | 2002-07-12 | 52 | 0 |
| K021017 | LEESPEC DISPOSABLE VAGINAL SPECULUM | Itl Corporation Pty, Ltd. | 2002-06-19 | 82 | 0 |
| K020959 | GLO-SPEC I, II AND III | Sol Weiss MD, Inc. | 2002-06-19 | 86 | 0 |
| K020726 | DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE | Dukal Corp. | 2002-05-15 | 70 | 0 |
| K012535 | DRG DISPOSABLE VAGINAL SPECULUM | Doctor'S Research Group, Inc. | 2002-03-01 | 206 | 0 |
| K013835 | GLOBAL HEALTHCARE VAGINAL SPECULUM | Dynascend Consulting Int'L, LLC | 2002-01-17 | 59 | 0 |
| K013817 | GLO-SPEC | Sol Weiss MD, Inc. | 2001-12-21 | 35 | 0 |
| K012859 | NU-SPEC D | Sol Weiss MD, Inc. | 2001-10-26 | 63 | 0 |
| K002912 | VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / | Sterinc | 2001-02-21 | 156 | 0 |
| K003540 | (DISPOSABLE) VAGINAL SPECULUM | Feminica, Inc. | 2001-02-09 | 85 | 0 |
| K000444 | MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM | Prism Enterprises, Inc. | 2000-04-21 | 71 | 0 |
| K000414 | MEDISUL DISPOSABLE VAGINAL SPECULUM | Marketing Perspectives | 2000-04-04 | 56 | 0 |
| K992736 | WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM | Wallach Surgical Devices, Inc. | 1999-09-29 | 47 | 0 |
| K991963 | PATTON SPECULUM | Patton Medical Corp. | 1999-09-01 | 83 | 0 |
| K991827 | GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS | Ri Mos. S.R.L. | 1999-07-19 | 52 | 0 |
| K984211 | MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLAS | Medscand AB | 1998-12-23 | 29 | 0 |
| K983716 | VITALCARE DISPOSABLE VAGINAL SPECULUM | Vitalcare Group, Inc. | 1998-12-23 | 63 | 0 |
| K973853 | KOLPLAST VAGINAL SPECULUM | Kolplast Comercial E Industrial Ltda | 1997-12-19 | 72 | 0 |
| K974228 | HOSPITAL'S SPEC | Gps | 1997-12-12 | 30 | 0 |
| K971979 | PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIM | Playtex Products, Inc. | 1997-09-26 | 120 | 0 |
| K925501 | NYLON COATED SPECULA | Zinnanti Surgical Instruments, Inc. | 1997-06-13 | 1687 | 0 |
| K963377 | EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC | North Eos Industries, Inc. | 1996-10-04 | 38 | 0 |
| K951898 | VERSA-VU | CooperSurgical, Inc. | 1995-12-11 | 231 | 0 |
| K951528 | AMSINO DISPOSABLE VIGINAL SPECULUM | Amsino Intl., Inc. | 1995-05-11 | 38 | 0 |
| K941272 | KLEENSPEC | Welch Allyn, Inc. | 1994-08-02 | 139 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda