Cleared Traditional

K052314 - DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE

K052314 is an FDA 510(k) clearance for DYNAREX VAGINAL SPECULA 4900, manufactured by Dynarex Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K052314 · Dynarex Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
76d
Days
Class 2
Risk

K052314 is an FDA 510(k) clearance for the DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Dynarex Corp. (Orangeburg, US). The FDA issued a Cleared decision on November 9, 2005 after a review of 76 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.

View all Dynarex Corp. devices

FDA 510(k) Submission Details - K052314

510(k) Number K052314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2005
Decision Date November 09, 2005
Days to Decision 76 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
85d faster than avg
Panel avg: 161d · This submission: 76d
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 55
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K052314.
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
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K052192 · Femspec LLC · Feb 2006
YUSHENG DISPOSABLE VAGINAL SPECULUM
K052912 · Zhejiang Yusheng Medical Instrument Co. , Ltd. · Dec 2005
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