Cleared Traditional

K180167 - Playtex Stella Tampons

K180167 is the FDA 510(k) clearance for Playtex Stella Tampons by Playtex Manufacturing, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HEB) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K180167 · Playtex Manufacturing, Inc. · Obstetrics & Gynecology device
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May 2018
Decision
128d
Days
Class 2
Risk

K180167 is an FDA 510(k) clearance for the Playtex Stella Tampons. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Playtex Manufacturing, Inc. (Dover, US). The FDA issued a Cleared decision on May 30, 2018 after a review of 128 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 Playtex Manufacturing, Inc. devices

Submission Details

510(k) Number K180167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2018
Decision Date May 30, 2018
Days to Decision 128 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
32d faster than avg
Panel avg: 160d · This submission: 128d
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.

Regulatory Consultant

Edgewell Personal Care
Danielle Vitale

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 85
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K180167.
Interlude 100% Cotton Tampon
K181911 · Albaad Fem · Nov 2018
re.t.a Reuseable Tampon Applicator
K180850 · Thinx, Inc. · Aug 2018
Interlude and private label Unscented 3-piece compact applicator tampon
K173225 · Albaad Fem · Jun 2018
Tosama Biobased Applicator Tube Menstrual Tampon
K172504 · Tosama, D.O.O. · Feb 2018
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
K141294 · Kimberly-Clark Corp. · Aug 2014
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
K112635 · Kimberly-Clark Corp. · Oct 2011