Cleared Traditional

K041757 - FEMSPEC DISPOSABLE VAGINAL SPECULUM

K041757 is an FDA 510(k) clearance for FEMSPEC DISPOSABLE VAGINAL SPECULUM, manufactured by Femspec LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K041757 · Femspec LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
177d
Days
Class 2
Risk

K041757 is an FDA 510(k) clearance for the FEMSPEC DISPOSABLE VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Femspec LLC (San Francisco, US). The FDA issued a Cleared decision on December 23, 2004 after a review of 177 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.

FDA 510(k) Submission Details - K041757

510(k) Number K041757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2004
Decision Date December 23, 2004
Days to Decision 177 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
16d slower than avg
Panel avg: 161d · This submission: 177d
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 65
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K041757.
YUSHENG DISPOSABLE VAGINAL SPECULUM
K052912 · Zhejiang Yusheng Medical Instrument Co. , Ltd. · Dec 2005
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
K052314 · Dynarex Corp. · Nov 2005
GONGDONG DISPOSABLE VAGINAL SPECULUM
K050887 · Zhejiang Gongdong Medical Plastic Factory · Jul 2005
VAG O SPECULUM, MODELS VS1, VM1, VL1
K042950 · Panatrex, Inc. · Nov 2004
POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM
K040817 · Advanced Urological Developments · Jun 2004
KENTEX DISPOSABLE VAGINAL SPECULUM
K030693 · Kentron Health Care, Inc. · Aug 2003
K041757 · FEMSPEC DISPOSABLE VAGINAL SPECULUM
Download PDF FDA Summary Femspec LLC