FDA.reportPublic FDA data

510(k) K252208

Device
JFord Speculum Sleeve™
Applicant
Ford Medtech, LLC
510(k) number
K252208
Product code
HIB
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-06
Date received
2025-07-15
Regulation
884.4530
Classification name
Speculum, Vaginal, Nonmetal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jacqueline Ford
Address
251 Post Ave., 2nd Floor Westbury NY US 11590 11590

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HIB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K133857BRELLA-SPEC(TM) VAGINAL SPECULUMProa Medical, Inc.2014-04-28
K132668IOB DISPOSABLE SPECULUMIob Medical, Inc.2014-01-17
K130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLC2013-08-06
K120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.2012-03-23
K110766KOLPLUX SYSTEMKolplast CI Ltda2011-09-15
K092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.2010-02-16
K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation2009-09-09
K072942MEDLINE DISPOSABLE VAGINAL SPECULUMMedline Industries, Inc.2008-02-08
K072762DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEMDepalt, Inc.2008-01-22
K070964KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEMWelch Allyn, Inc.2007-05-18
K061339HIERSPEC SPECULUMMedical Products Div.2006-09-19
K060129IGS VAGINAL SPECULUMInnovative Gynecological Solutions, LLC2006-05-04
K052420G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUMGynova, LLC2006-04-06
K052192FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-IFemspec LLC2006-02-02
K052912YUSHENG DISPOSABLE VAGINAL SPECULUMZhejiang Yusheng Medical Instrument Co. , Ltd.2005-12-15