Cleared Traditional

K953333 - MENSTRUAL TAMPON

K953333 is an FDA 510(k) clearance for MENSTRUAL TAMPON, manufactured by Paragon Trade Brands, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K953333 · Paragon Trade Brands, Inc. · Obstetrics & Gynecology device
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Dec 1995
Decision
142d
Days
Class 2
Risk

K953333 is an FDA 510(k) clearance for the MENSTRUAL TAMPON. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Paragon Trade Brands, Inc. (Federal Way, US). The FDA issued a Cleared decision on December 6, 1995 after a review of 142 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Paragon Trade Brands, Inc. devices

FDA 510(k) Submission Details - K953333

510(k) Number K953333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date December 06, 1995
Days to Decision 142 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 160d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEB Device Classification - Class 2, Special Controls

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 137
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K953333.
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
K960341 · Tambrands, Inc. · Apr 1996
NON APPLICATOR TAMPON, UNTREATED
K954445 · Hygieia Healthcare , Ltd. · Feb 1996
NATRACAREN APPLICATOR TAMPON
K954942 · Bodywise (Uk), Ltd. · Jan 1996
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894
K944064 · Playtex, Inc. · Feb 1995
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22994
K944154 · Playtex Products, Inc. · Feb 1995
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #23094
K944155 · Playtex Products, Inc. · Feb 1995