Cleared Traditional

K880735 - UNSCENTED MENSTRUAL PADS

K880735 is an FDA 510(k) clearance for UNSCENTED MENSTRUAL PADS, manufactured by Personal Products Co.. The device is a Class 1 Obstetrics & Gynecology device with product code HHD cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K880735 · Personal Products Co. · Obstetrics & Gynecology device
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Apr 1988
Decision
61d
Days
Class 1
Risk

K880735 is an FDA 510(k) clearance for the UNSCENTED MENSTRUAL PADS. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Personal Products Co. (Milltown, US). The FDA issued a Cleared decision on April 25, 1988 after a review of 61 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 - K880735

510(k) Number K880735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1988
Decision Date April 25, 1988
Days to Decision 61 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
100d faster than avg
Panel avg: 161d · This submission: 61d
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 135
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K880735.
LAURIER SANITARY NAPKIN
K882768 · Kao Corp. · Aug 1988
KOTEX LIGHTDAYS LONGS DEODORANT & REG. PANTILINERS
K882364 · Kimberly-Clark Corp. · Aug 1988
DISPOSEABLE MENSTRUAL PANTY
K882109 · Glamor Plus Co. · Jul 1988
SANITARY MENSTRUAL NAPKIN
K875309 · Universal Health Care Products Canada, Inc. · Mar 1988
LADY FREE UNSCENTED MENSTRUAL PAD
K872287 · American Tissue Corp. · Aug 1987
LAURIER NIGHT SAFE EXTRA PROTECTION SANITARY NAP.
K872481 · Kao Corp. · Aug 1987
K880735 · UNSCENTED MENSTRUAL PADS
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