Cleared Traditional

K844935 - ORIGINAL REGULAR TAMPAX TAMPONS

K844935 is the FDA 510(k) clearance for ORIGINAL REGULAR TAMPAX TAMPONS by Tambrands, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HEB) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K844935 · Tambrands, Inc. · Obstetrics & Gynecology device
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Feb 1985
Decision
50d
Days
Class 2
Risk

K844935 is an FDA 510(k) clearance for the ORIGINAL REGULAR TAMPAX TAMPONS. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Tambrands, Inc. (Washington, US). The FDA issued a Cleared decision on February 7, 1985 after a review of 50 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 K844935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1984
Decision Date February 07, 1985
Days to Decision 50 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
110d faster than avg
Panel avg: 160d · This submission: 50d
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 K844935.
SLENDER REGULAR TAMPAX TAMPONS
K861913 · Tambrands, Inc. · Aug 1986
KOTEX SECURITY TUBE TAMPON
K853192 · Kimberly-Clark Corp. · Aug 1985
UNSCENTED MENSTRUAL TAMPONS
K851941 · Personal Products Co. · Aug 1985
SUPER TAMPAX TAMPONS
K844936 · Tambrands, Inc. · Feb 1985
SUPER PETAL SOFT PLASTIC APPLICATOR TAMP
K842618 · Tambrands, Inc. · Jul 1984
REGULAR PETAL SOFT PLASTIC APPLICATOR
K842619 · Tambrands, Inc. · Jul 1984