Cleared Traditional

K130046 - CLEARSPEC SINGLE USE VAGINAL SPECULUM

K130046 is an FDA 510(k) clearance for CLEARSPEC SINGLE USE VAGINAL SPECULUM, manufactured by Clearspec, LLC. The device is a Class 2 Obstetrics & Gynecology device with product code HIB cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K130046 · Clearspec, LLC · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
210d
Days
Class 2
Risk

K130046 is an FDA 510(k) clearance for the CLEARSPEC SINGLE USE VAGINAL SPECULUM. Classified as Speculum, Vaginal, Nonmetal (product code HIB), Class II - Special Controls.

Submitted by Clearspec, LLC (Herkimer, US). The FDA issued a Cleared decision on August 6, 2013 after a review of 210 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K130046

510(k) Number K130046 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2013
Decision Date August 06, 2013
Days to Decision 210 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
49d slower than avg
Panel avg: 161d · This submission: 210d
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 65
Devices cleared under the same product code (HIB) and FDA review panel - the closest regulatory comparables to K130046.
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BRELLA-SPEC(TM) VAGINAL SPECULUM
K133857 · Proa Medical, Inc. · Apr 2014
IOB DISPOSABLE SPECULUM
K132668 · Iob Medical, Inc. · Jan 2014
SPECULUM, VAGINAL, NONMETAL
K120743 · Welch Allyn, Inc. · Mar 2012
KOLPLUX SYSTEM
K110766 · Kolplast CI Ltda · Sep 2011
NON-STERILE DISPOSABLE VAGINAL SPECULUM
K092870 · Kunshan Deyi Plastic Co., Ltd. · Feb 2010
K130046 · CLEARSPEC SINGLE USE VAGINAL SPECULUM
Download PDF FDA Summary Clearspec, LLC