Cleared Traditional

K953487 - UNSCENTED MENSTRUAL SHIELD

K953487 is an FDA 510(k) clearance for UNSCENTED MENSTRUAL SHIELD, manufactured by Paragon Trade Brands, Inc.. The device is a Class 1 Obstetrics & Gynecology device with product code HHD cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K953487 · Paragon Trade Brands, Inc. · Obstetrics & Gynecology device
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Aug 1995
Decision
15d
Days
Class 1
Risk

K953487 is an FDA 510(k) clearance for the UNSCENTED MENSTRUAL SHIELD. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Paragon Trade Brands, Inc. (Federal Way, US). The FDA issued a Cleared decision on August 9, 1995 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 884.5435 - 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.

FDA 510(k) Submission Details - K953487

510(k) Number K953487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1995
Decision Date August 09, 1995
Days to Decision 15 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d faster than avg
Panel avg: 161d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

HHD Device Classification - Class 1, General Controls

Product Code HHD Pad, Menstrual, Unscented
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.5435
Definition An Unscented Menstrual Pad Which Is Used To Absorb Menstrual Fluid Or Other Vaginal Discharge And Is Made Of Common Cellulosic And Synthetic Material With An Established Safety Profile.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HHD Pad, Menstrual, Unscented

All 106
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K953487.
UNSCENTED MENSTRUAL PAD
K953517 · Paragon Trade Brands, Inc. · Oct 1995
UNSCENTED MENSTRAL PAD WITH WINGS
K953666 · Paragon Trade Brands, Inc. · Sep 1995
UNSCENTED CURVED MAXI PAD
K953700 · Paragon Trade Brands, Inc. · Sep 1995
UNSCENTED MENSTRUAL LINER
K953488 · Paragon Trade Brands, Inc. · Aug 1995
CARESS SANITARY NAPKIN
K951693 · Sterling U.S.A., Inc. · Jul 1995
REUSABLE MENSTRUAL PAD
K924502 · Keema and Co. · Nov 1994
K953487 · UNSCENTED MENSTRUAL SHIELD
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