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)
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.

View all Femspec LLC devices

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
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 160d · 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 24
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K041757.
MEDLINE DISPOSABLE VAGINAL SPECULUM
K072942 · Medline Industries, Inc. · Feb 2008
KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
K070964 · Welch Allyn, Inc. · May 2007
DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
K052314 · Dynarex Corp. · Nov 2005
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
K021676 · Cypress Medical Products, Ltd. · Jul 2002
WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
K992736 · Wallach Surgical Devices, Inc. · Sep 1999
PATTON SPECULUM
K991963 · Patton Medical Corp. · Sep 1999