Cleared Traditional

K896994 - KOTEX SECURITY TAMPONS (SEVERAL TYPE)

K896994 is an FDA 510(k) clearance for KOTEX SECURITY TAMPONS (SEVERAL TYPE), 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 11-day FDA review.

K896994 · Kimberly-Clark Corp. · Obstetrics & Gynecology device
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Dec 1989
Decision
11d
Days
Class 2
Risk

K896994 is an FDA 510(k) clearance for the KOTEX SECURITY TAMPONS (SEVERAL TYPE). 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 December 22, 1989 after a review of 11 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 - K896994

510(k) Number K896994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1989
Decision Date December 22, 1989
Days to Decision 11 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
149d faster than avg
Panel avg: 160d · This submission: 11d
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 K896994.
UNSCENTED MENSTRUAL TAMPON
K897007 · Personal Products Co. · Jul 1990
MENSTRUAL TAMPON
K897008 · Personal Products Co. · Jan 1990
TAMPAX TAMPON
K896989 · Tambrands, Inc. · Dec 1989
TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS
K896112 · Tambrands, Inc. · Dec 1989
TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS
K896113 · Tambrands, Inc. · Dec 1989
TAMPON, PETAL SOFT PLASTIC APPLI., SUPER ABSORB.
K896114 · Tambrands, Inc. · Dec 1989