Cleared Traditional

K030693 - KENTEX DISPOSABLE VAGINAL SPECULUM

K030693 is an FDA 510(k) clearance for KENTEX DISPOSABLE VAGINAL SPECULUM, manufactured by Kentron Health Care, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K030693 · Kentron Health Care, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
175d
Days
Class 2
Risk

K030693 is an FDA 510(k) clearance for the KENTEX DISPOSABLE VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Kentron Health Care, Inc. (Springfield, US). The FDA issued a Cleared decision on August 27, 2003 after a review of 175 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kentron Health Care, Inc. devices

FDA 510(k) Submission Details - K030693

510(k) Number K030693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2003
Decision Date August 27, 2003
Days to Decision 175 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 161d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIB Device Classification - Class 2, Special Controls

Product Code HIB Speculum, Vaginal, Nonmetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIB Speculum, Vaginal, Nonmetal

All 52
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K030693.
GONGDONG DISPOSABLE VAGINAL SPECULUM
K050887 · Zhejiang Gongdong Medical Plastic Factory · Jul 2005
FEMSPEC DISPOSABLE VAGINAL SPECULUM
K041757 · Femspec LLC · Dec 2004
VAG O SPECULUM, MODELS VS1, VM1, VL1
K042950 · Panatrex, Inc. · Nov 2004
KAISHOU VAGINAL SPECULUM
K030761 · Jiangsu Kaishou Medical Apparatus Co., Ltd. · Jun 2003
VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
K022948 · Medical Action Industries, Inc. · Nov 2002
TAGG DISPOSABLE VAGINAL SPECULUM
K021849 · Tagg Industries · Jul 2002