Cleared Traditional

KOTEX SECURITY TUBE TAMPONS (K885194) - FDA 510(k) Clearance

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

K885194 · Kimberly-Clark Corp. · Obstetrics & Gynecology device
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Mar 1989
Decision
75d
Days
Class 2
Risk

K885194 is an FDA 510(k) clearance for the KOTEX SECURITY TUBE TAMPONS. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Washington, US). The FDA issued a Cleared decision on March 1, 1989 after a review of 75 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 Corp. devices

Submission Details

510(k) Number K885194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1988
Decision Date March 01, 1989
Days to Decision 75 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 160d · This submission: 75d
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 Peers - HEB Tampon, Menstrual, Unscented

All 38
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K885194.
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
JOHNSON & JOHNSON O.B. TAMPONS
K811983 · Johnson & Johnson Professionals, Inc. · Jul 1981