Cleared Traditional

K812402 - UNSCENTED MENSTRUAL PADS

K812402 is an FDA 510(k) clearance for UNSCENTED MENSTRUAL PADS, manufactured by Procter & Gamble Mfg. Co.. The device is a Class 1 Obstetrics & Gynecology device with product code HHD cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K812402 · Procter & Gamble Mfg. Co. · Obstetrics & Gynecology device
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Sep 1981
Decision
20d
Days
Class 1
Risk

K812402 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 September 9, 1981 after a review of 20 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 - K812402

510(k) Number K812402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1981
Decision Date September 09, 1981
Days to Decision 20 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
141d faster than avg
Panel avg: 161d · This submission: 20d
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 K812402.
UNSCENTED MENSTRUAL PADS-MAXI PADS
K813251 · I.C.D. Industries, Inc. · Dec 1981
UNSCENTED MENSTRUAL PADS-MINI PADS
K813252 · I.C.D. Industries, Inc. · Dec 1981
UNSCENTED MENSTRUAL PADS
K812577 · Weyerhaeuser Co. · Oct 1981
CYCLES REUSABLE MENSTRUAL PADS
K812333 · Cycles · Sep 1981
OBSTETRICAL PAD(STEAM STERILIZED)
K812232 · Paper-Pak Products, Inc. · Aug 1981
UNSCENTED MENSTRUAL PADS
K811869 · Procter & Gamble Mfg. Co. · Jul 1981
K812402 · UNSCENTED MENSTRUAL PADS
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