Cleared Traditional

K831707 - MODIFIED UNSCENTED MENSTRUAL PADS

K831707 is the FDA 510(k) clearance for MODIFIED UNSCENTED MENSTRUAL PADS by Personal Products Co.. It is a Class 1 Obstetrics & Gynecology device (product code HHD) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K831707 · Personal Products Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
21d
Days
Class 1
Risk

K831707 is an FDA 510(k) clearance for the MODIFIED UNSCENTED MENSTRUAL PADS. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Personal Products Co. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983 after a review of 21 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 Personal Products Co. devices

Submission Details

510(k) Number K831707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1983
Decision Date June 16, 1983
Days to Decision 21 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
139d faster than avg
Panel avg: 160d · This submission: 21d
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 K831707.
UNSCENTED MENSTRUAL PAD
K842763 · Procter & Gamble Mfg. Co. · Aug 1984
SURE & NATURAL MAXI-SHIELD
K842480 · Johnson & Johnson Professionals, Inc. · Jul 1984
UNSCENTED MENSTRUAL PAD
K834144 · Procter & Gamble Mfg. Co. · Dec 1983
PANTY-LINERS UNSCENTED
K830145 · Procter & Gamble Mfg. Co. · Jan 1983
UNSCENTED MENSTRUAL PADS
K823477 · Procter & Gamble Mfg. Co. · Jan 1983
NEW FREEDOM THIN UNSCENTED MAXI PADS
K823241 · Kimberly-Clark Corp. · Dec 1982