Cleared Traditional

K020726 - DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE

K020726 is an FDA 510(k) clearance for DUKAL DISPOSABLE VAGINAL SPECULUM, manufactured by Dukal Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K020726 · Dukal Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
70d
Days
Class 2
Risk

K020726 is an FDA 510(k) clearance for the DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Dukal Corp. (New Port Riche, US). The FDA issued a Cleared decision on May 15, 2002 after a review of 70 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 - K020726

510(k) Number K020726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2002
Decision Date May 15, 2002
Days to Decision 70 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
91d faster than avg
Panel avg: 161d · This submission: 70d
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 58
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K020726.
CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL
K021676 · Cypress Medical Products, Ltd. · Jul 2002
GLO-SPEC I, II AND III
K020959 · Sol Weiss MD, Inc. · Jun 2002
LEESPEC DISPOSABLE VAGINAL SPECULUM
K021017 · Itl Corporation Pty, Ltd. · Jun 2002
DRG DISPOSABLE VAGINAL SPECULUM
K012535 · Doctor'S Research Group, Inc. · Mar 2002
GLOBAL HEALTHCARE VAGINAL SPECULUM
K013835 · Dynascend Consulting Int'L, LLC · Jan 2002
GLO-SPEC
K013817 · Sol Weiss MD, Inc. · Dec 2001
K020726 · DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
Download PDF FDA Summary Dukal Corp.