Cleared Traditional

K040999 - TAMPAX TAMPONS (JUNIOR

K040999 is the FDA 510(k) clearance for TAMPAX TAMPONS (JUNIOR by Procter & Gamble Co.. It is a Class 2 Obstetrics & Gynecology device (product code HEB) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K040999 · Procter & Gamble Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
81d
Days
Class 2
Risk

K040999 is an FDA 510(k) clearance for the TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES). Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Procter & Gamble Co. (Cincinnati, US). The FDA issued a Cleared decision on July 9, 2004 after a review of 81 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 Procter & Gamble Co. devices

Submission Details

510(k) Number K040999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2004
Decision Date July 09, 2004
Days to Decision 81 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 160d · This submission: 81d
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 86
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K040999.
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
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
K091749 · Kimberly-Clark Corp. · Dec 2009
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
K962476 · Tambrands, Inc. · Aug 1996
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
K960341 · Tambrands, Inc. · Apr 1996
UNSCENTED MENSTRUAL TAMPONS
K944834 · Tambrands, Inc. · Dec 1994