Cleared Traditional

K871642 - TAMPAX TAMPON

K871642 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 15-day FDA review.

K871642 · Tambrands, Inc. · Obstetrics & Gynecology device
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May 1987
Decision
15d
Days
Class 2
Risk

K871642 is an FDA 510(k) clearance for the TAMPAX TAMPON, REGULAR. 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 May 12, 1987 after a review of 15 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 K871642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1987
Decision Date May 12, 1987
Days to Decision 15 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
145d faster than avg
Panel avg: 160d · This submission: 15d
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 K871642.
KOTEX STICK TAMPONS, REGULAR AND SUPER
K884305 · Kimberly-Clark Corp. · Dec 1988
ADVERTISING AND LABEL CHANGE ON TAMBRANDS TAMPONS
K871715 · Tambrands, Inc. · Jun 1987
KOTEX STICK TAMPONS, REGULAR AND SUPER
K872018 · Kimberly-Clark Corp. · Jun 1987
O.B. SLENDER REGULAR TAMPON
K870539 · Personal Products Co. · Mar 1987
SUPER PLUS PETAL SOFT PLASTIC APPLICATOR TAMPONS
K864648 · Tambrands, Inc. · Mar 1987
REGULAR PETAL SOFT PLASTIC APPLICATOR TAMPONS
K864649 · Tambrands, Inc. · Mar 1987