Cleared Traditional

K924303 - TAMPAX TAMPON

K924303 is the FDA 510(k) clearance for TAMPAX TAMPON by Tambrands, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HEB) cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K924303 · Tambrands, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Jul 1993
Decision
358d
Days
Class 2
Risk

K924303 is an FDA 510(k) clearance for the TAMPAX TAMPON, REGULAR ABSORBENCY. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Tambrands, Inc. (Palmer, US). The FDA issued a Cleared decision on July 29, 1993 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Tambrands, Inc. devices

Submission Details

510(k) Number K924303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1992
Decision Date July 29, 1993
Days to Decision 358 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
198d slower than avg
Panel avg: 160d · This submission: 358d
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 99
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K924303.
O.B. TAMPON
K941863 · Personal Products Co. · Jun 1994
KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+
K930149 · Kimberly-Clark Corp. · Mar 1994
TAMPAX TAMPONS, SUPER ABSORBENCY
K923932 · Tambrands, Inc. · Jul 1993
UNSCENTED MENSTRUAL TAMPON
K923985 · Personal Products Co. · Feb 1993
UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR
K912552 · Personal Products Co. · Sep 1991
UNSCENTED MENSTRUAL TAMPON
K897007 · Personal Products Co. · Jul 1990