Cleared Traditional

K223749 - 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.

K223749 · Kimberly Clark Corporation · Obstetrics & Gynecology device

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Optimized for regulatory review, auditing and printing

Jan 2023

Decision

23d

Days

Class 2

Risk

K223749 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 January 6, 2023 after a review of 23 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kimberly Clark Corporation devices

Submission Details

510(k) Number	K223749 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 14, 2022
Decision Date	January 06, 2023
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF
Third-party Review	Yes - reviewed by an FDA-accredited third party

Regulatory Context

Review time vs. panel average

137d faster than avg

Panel avg: 160d · This submission: 23d

Pathway characteristics

Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.