Cleared Traditional

K896989 - TAMPAX TAMPON

K896989 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 10-day FDA review.

K896989 · Tambrands, Inc. · Obstetrics & Gynecology device
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Dec 1989
Decision
10d
Days
Class 2
Risk

K896989 is an FDA 510(k) clearance for the TAMPAX TAMPON. 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 December 22, 1989 after a review of 10 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 K896989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1989
Decision Date December 22, 1989
Days to Decision 10 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
150d faster than avg
Panel avg: 160d · This submission: 10d
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 K896989.
UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR
K912552 · Personal Products Co. · Sep 1991
UNSCENTED MENSTRUAL TAMPON
K897007 · Personal Products Co. · Jul 1990
MENSTRUAL TAMPON
K897008 · Personal Products Co. · Jan 1990
KOTEX SECURITY TAMPONS (SEVERAL TYPE)
K896994 · Kimberly-Clark Corp. · 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