Cleared Abbreviated

K000414 - MEDISUL DISPOSABLE VAGINAL SPECULUM

K000414 is an FDA 510(k) clearance for MEDISUL DISPOSABLE VAGINAL SPECULUM, manufactured by Marketing Perspectives. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Abbreviated 510(k) pathway after a 56-day FDA review.

K000414 · Marketing Perspectives · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
56d
Days
Class 2
Risk

K000414 is an FDA 510(k) clearance for the MEDISUL DISPOSABLE VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Marketing Perspectives (Holland, US). The FDA issued a Cleared decision on April 4, 2000 after a review of 56 days - a notably fast clearance 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Marketing Perspectives devices

FDA 510(k) Submission Details - K000414

510(k) Number K000414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2000
Decision Date April 04, 2000
Days to Decision 56 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 160d · This submission: 56d
Pathway characteristics
Standards-based clearance path.

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 33
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K000414.
FEMSPEC DISPOSABLE VAGINAL SPECULUM
K041757 · Femspec LLC · Dec 2004
VAG O SPECULUM, MODELS VS1, VM1, VL1
K042950 · Panatrex, Inc. · Nov 2004
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
GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043
K991827 · Ri Mos. S.R.L. · Jul 1999