FDA.report

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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

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

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code HIB

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