Cleared Traditional

K172118 - U by Kotex Click Unscented Menstrual Tampons (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172118 · Kimberly Clark Corporation · Obstetrics & Gynecology device

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Oct 2017

Decision

90d

Days

Class 2

Risk

K172118 is an FDA 510(k) clearance for the U by Kotex Click Unscented Menstrual Tampons. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Kimberly Clark Corporation (Neenah, US). The FDA issued a Cleared decision on October 11, 2017 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5470 - 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.

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Submission Details

510(k) Number	K172118 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 13, 2017
Decision Date	October 11, 2017
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

70d faster than avg

Panel avg: 160d · This submission: 90d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	HEB Tampon, Menstrual, Unscented
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 884.5470
Definition	An Unscented Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.

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.