Cleared Traditional

K842763 - UNSCENTED MENSTRUAL PAD

K842763 is the FDA 510(k) clearance for UNSCENTED MENSTRUAL PAD by Procter & Gamble Mfg. Co.. It is a Class 1 Obstetrics & Gynecology device (product code HHD) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K842763 · Procter & Gamble Mfg. Co. · Obstetrics & Gynecology device
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Aug 1984
Decision
25d
Days
Class 1
Risk

K842763 is an FDA 510(k) clearance for the UNSCENTED MENSTRUAL PAD. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1984 after a review of 25 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.

View all Procter & Gamble Mfg. Co. devices

Submission Details

510(k) Number K842763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1984
Decision Date August 10, 1984
Days to Decision 25 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
135d faster than avg
Panel avg: 160d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 53
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K842763.
MAXITHINS BODY-SHAPED PANTY SHIELDS
K842951 · Tambrands, Inc. · Aug 1984
REGULAR MAXITHINS BODY-SHAPED MAXI
K842952 · Tambrands, Inc. · Aug 1984
ASSURE-BREATHABLE PANTY LINERS/UNSCENT
K841311 · Personal Products Co. · Aug 1984
SURE & NATURAL MAXI-SHIELD
K842480 · Johnson & Johnson Professionals, Inc. · Jul 1984
UNSCENTED MENSTRUAL PAD
K834144 · Procter & Gamble Mfg. Co. · Dec 1983
MODIFIED UNSCENTED MENSTRUAL PADS
K831707 · Personal Products Co. · Jun 1983