Cleared Traditional

K812577 - UNSCENTED MENSTRUAL PADS

K812577 is the FDA 510(k) clearance for UNSCENTED MENSTRUAL PADS by Weyerhaeuser Co.. It is a Class 1 Obstetrics & Gynecology device (product code HHD) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K812577 · Weyerhaeuser Co. · Obstetrics & Gynecology device

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Oct 1981

Decision

40d

Days

Class 1

Risk

K812577 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 Weyerhaeuser Co. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1981 after a review of 40 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 Weyerhaeuser Co. devices

Submission Details

510(k) Number	K812577 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 09, 1981
Decision Date	October 19, 1981
Days to Decision	40 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

120d faster than avg

Panel avg: 160d · This submission: 40d

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 54

Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K812577.

SURE & NATURAL MAXISHIELDS

K823239 · Personal Products Co. · Dec 1982

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

UNSCENTED MENSTRUAL PADS

K811869 · Procter & Gamble Mfg. Co. · Jul 1981

CONFI-DRY ADULT UROABSORBENT PADS

K811766 · Personal Products Co. · Jul 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K812577

Weyerhaeuser Co.

Mchenry, IL · US

Regulatory profile

10 submissions 10 cleared

100% clearance rate · Active in Obstetrics & Gynecology

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Sourced from FDA 510(k) public files . Updated monthly.

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