Cleared Traditional

K861906 - TAMPAX JUNIOR TAMPONS

K861906 is the FDA 510(k) clearance for TAMPAX JUNIOR TAMPONS by Tambrands, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HEB) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K861906 · Tambrands, Inc. · Obstetrics & Gynecology device
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Aug 1986
Decision
85d
Days
Class 2
Risk

K861906 is an FDA 510(k) clearance for the TAMPAX JUNIOR TAMPONS. 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 August 12, 1986 after a review of 85 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 K861906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1986
Decision Date August 12, 1986
Days to Decision 85 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
75d faster than avg
Panel avg: 160d · This submission: 85d
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 K861906.
TAMPAX CLOSED-END FLUSHABLE TAMPON, SLENDER REGU.
K870361 · Tambrands, Inc. · Feb 1987
KOTEX SECURITY TAMPONS, REGULAR AND SUPER
K864750 · Kimberly-Clark Corp. · Jan 1987
TAMPAX SUPER TAMPONS
K863464 · Tambrands, Inc. · Oct 1986
TAMPAX SUPER TAMPONS
K861907 · Tambrands, Inc. · Aug 1986
TAMPAX ORIGINAL REGULAR TAMPON
K861908 · Tambrands, Inc. · Aug 1986
REGULAR PETAL SOFT PLASTIC APPLI. TAMPAX TAMPONS
K861909 · Tambrands, Inc. · Aug 1986