Cleared Traditional

K802193 - KOTEX SECURITY TUBE TAMPONS

K802193 is an FDA 510(k) clearance for KOTEX SECURITY TUBE TAMPONS, manufactured by Kimberly-Clark Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K802193 · Kimberly-Clark Corp. · Obstetrics & Gynecology device
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Nov 1980
Decision
63d
Days
Class 2
Risk

K802193 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. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 63 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

FDA 510(k) Submission Details - K802193

510(k) Number K802193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1980
Decision Date November 12, 1980
Days to Decision 63 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 160d · This submission: 63d
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 Peers - HEB Tampon, Menstrual, Unscented

All 106
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K802193.
O.B. TAMPONS
K833179 · Personal Products Co. · Jan 1984
JOHNSON & JOHNSON O.B. TAMPONS
K811983 · Johnson & Johnson Professionals, Inc. · Jul 1981
ASSURE NATURAL FIT TAMPON
K811992 · Personal Products Co. · Jul 1981
RELY TAMPON
K791274 · Procter & Gamble Mfg. Co. · Aug 1979
KOTEX TUBE AND STICK TAMPON
K790385 · Kimberly-Clark Corp. · Mar 1979
TAMPON, RELY MODIFIED
K780243 · Procter & Gamble Mfg. Co. · Mar 1978