Cleared Special

K120743 - SPECULUM, VAGINAL, NONMETAL

K120743 is an FDA 510(k) clearance for SPECULUM, manufactured by Welch Allyn, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Special 510(k) pathway after a 11-day FDA review.

K120743 · Welch Allyn, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
11d
Days
Class 2
Risk

K120743 is an FDA 510(k) clearance for the SPECULUM, VAGINAL, NONMETAL. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on March 23, 2012 after a review of 11 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120743

510(k) Number K120743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2012
Decision Date March 23, 2012
Days to Decision 11 days
Submission Type Special
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
150d faster than avg
Panel avg: 161d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

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 68
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K120743.
BRELLA-SPEC(TM) VAGINAL SPECULUM
K133857 · Proa Medical, Inc. · Apr 2014
IOB DISPOSABLE SPECULUM
K132668 · Iob Medical, Inc. · Jan 2014
CLEARSPEC SINGLE USE VAGINAL SPECULUM
K130046 · Clearspec, LLC · Aug 2013
KOLPLUX SYSTEM
K110766 · Kolplast CI Ltda · Sep 2011
NON-STERILE DISPOSABLE VAGINAL SPECULUM
K092870 · Kunshan Deyi Plastic Co., Ltd. · Feb 2010
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
K091937 · Obp Corporation · Sep 2009
K120743 · SPECULUM, VAGINAL, NONMETAL
Download PDF FDA Summary Welch Allyn, Inc.