Cleared Traditional

K042950 - VAG O SPECULUM, MODELS VS1, VM1, VL1

K042950 is an FDA 510(k) clearance for VAG O SPECULUM, manufactured by Panatrex, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K042950 · Panatrex, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
35d
Days
Class 2
Risk

K042950 is an FDA 510(k) clearance for the VAG O SPECULUM, MODELS VS1, VM1, VL1. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Panatrex, Inc. (Placentia, US). The FDA issued a Cleared decision on November 30, 2004 after a review of 35 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042950

510(k) Number K042950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2004
Decision Date November 30, 2004
Days to Decision 35 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
126d faster than avg
Panel avg: 161d · This submission: 35d
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 K042950.
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
FEMSPEC DISPOSABLE VAGINAL SPECULUM
K041757 · Femspec LLC · Dec 2004
POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM
K040817 · Advanced Urological Developments · Jun 2004
KENTEX DISPOSABLE VAGINAL SPECULUM
K030693 · Kentron Health Care, Inc. · Aug 2003
KAISHOU VAGINAL SPECULUM
K030761 · Jiangsu Kaishou Medical Apparatus Co., Ltd. · Jun 2003
K042950 · VAG O SPECULUM, MODELS VS1, VM1, VL1
Download PDF FDA Summary Panatrex, Inc.