Cleared Traditional

K960341 - TAMPAX TAMPON WITH ADDITIVE JUNIOR

K960341 is the FDA 510(k) clearance for TAMPAX TAMPON WITH ADDITIVE JUNIOR by Tambrands, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HEB) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K960341 · Tambrands, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
84d
Days
Class 2
Risk

K960341 is an FDA 510(k) clearance for the TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS. 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 April 17, 1996 after a review of 84 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 Tambrands, Inc. devices

Submission Details

510(k) Number K960341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1996
Decision Date April 17, 1996
Days to Decision 84 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
76d faster than avg
Panel avg: 160d · This submission: 84d
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 K960341.
O.B. APPLICATOR AND NON-APPLICATOR TAMPONS
K974629 · Personal Products Co. · Feb 1998
O.B. APPLICATOR TAMPONS
K970954 · Personal Products Co. · Jun 1997
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
K962476 · Tambrands, Inc. · Aug 1996
UNSCENTED MENSTRUAL TAMPONS
K944834 · Tambrands, Inc. · Dec 1994
O.B. TAMPON
K941863 · Personal Products Co. · Jun 1994
KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+
K930149 · Kimberly-Clark Corp. · Mar 1994