Cleared Traditional

K811869 - UNSCENTED MENSTRUAL PADS

K811869 is the FDA 510(k) clearance for UNSCENTED MENSTRUAL PADS 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 15-day FDA review.

K811869 · Procter & Gamble Mfg. Co. · Obstetrics & Gynecology device
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Jul 1981
Decision
15d
Days
Class 1
Risk

K811869 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 Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981 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.

View all Procter & Gamble Mfg. Co. devices

Submission Details

510(k) Number K811869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date July 16, 1981
Days to Decision 15 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
145d faster than avg
Panel avg: 160d · This submission: 15d
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 K811869.
U.V.A.C. CURETTES
K822756 · American Hospital Supply Corp. · Sep 1982
CAREFREE PANTY SHIELDS
K820522 · Personal Products Co. · Mar 1982
UNSCENTED MENSTRUAL PADS
K812402 · Procter & Gamble Mfg. Co. · Sep 1981
CONFI-DRY ADULT UROABSORBENT PADS
K811766 · Personal Products Co. · Jul 1981
SANITARY/OB PAD
K792296 · American Hospital Supply Corp. · Dec 1979
MODESS* BELTLESS FEMININE NAPKIN
K781470 · Personal Products Co. · Sep 1978