Cleared Traditional

K021017 - LEESPEC DISPOSABLE VAGINAL SPECULUM

K021017 is an FDA 510(k) clearance for LEESPEC DISPOSABLE VAGINAL SPECULUM, manufactured by Itl Corporation Pty, Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K021017 · Itl Corporation Pty, Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
82d
Days
Class 2
Risk

K021017 is an FDA 510(k) clearance for the LEESPEC DISPOSABLE VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Itl Corporation Pty, Ltd. (Fyshwick, Canberra Act, AU). The FDA issued a Cleared decision on June 19, 2002 after a review of 82 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 - K021017

510(k) Number K021017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2002
Decision Date June 19, 2002
Days to Decision 82 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
79d faster than avg
Panel avg: 161d · This submission: 82d
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 K021017.
TAGG DISPOSABLE VAGINAL SPECULUM
K021849 · Tagg Industries · Jul 2002
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
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
K020726 · Dukal Corp. · May 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
K021017 · LEESPEC DISPOSABLE VAGINAL SPECULUM
Download PDF FDA Summary Itl Corporation Pty, …