Cleared Traditional

K172118 - U by Kotex Click Unscented Menstrual Tampons

K172118 is an FDA 510(k) clearance for U by Kotex Click Unscented Menstrual Ta..., manufactured by Kimberly Clark Corporation. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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.

View all Kimberly Clark Corporation devices

FDA 510(k) Submission Details - K172118

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 161d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEB Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Kimberly-Clark Corp.
Lori J. Barr

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HEB Tampon, Menstrual, Unscented

All 166
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K172118.
Interlude and private label Unscented 3-piece compact applicator tampon
K173225 · Albaad Fem · Jun 2018
Playtex Stella Tampons
K180167 · Playtex Manufacturing, Inc. · May 2018
Tosama Biobased Applicator Tube Menstrual Tampon
K172504 · Tosama, D.O.O. · Feb 2018
Ontex and other proprietary names
K162746 · Ontex Bvba · Mar 2017
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl
K161877 · First Quality Hygienic, Inc. · Aug 2016
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS
K152284 · Cotton High Tech S.L. · Dec 2015