Cleared Special

K070964 - KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM

K070964 is an FDA 510(k) clearance for KLEENSPEC SINGLE USE VAGINAL SPECULUM A..., 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 43-day FDA review.

K070964 · Welch Allyn, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
43d
Days
Class 2
Risk

K070964 is an FDA 510(k) clearance for the KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SY.... 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 May 18, 2007 after a review of 43 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 - K070964

510(k) Number K070964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2007
Decision Date May 18, 2007
Days to Decision 43 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
118d faster than avg
Panel avg: 161d · This submission: 43d
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 71
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K070964.
OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUM
K091937 · Obp Corporation · Sep 2009
MEDLINE DISPOSABLE VAGINAL SPECULUM
K072942 · Medline Industries, Inc. · Feb 2008
DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM
K072762 · Depalt, Inc. · Jan 2008
HIERSPEC SPECULUM
K061339 · Medical Products Div. · Sep 2006
IGS VAGINAL SPECULUM
K060129 · Innovative Gynecological Solutions, LLC · May 2006
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
K052420 · Gynova, LLC · Apr 2006
K070964 · KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
Download PDF FDA Summary Welch Allyn, Inc.