Cleared Traditional

PADS, MINI, MAXI (K782112) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K782112 · Intl. Playtex, Inc. · Obstetrics & Gynecology device
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Jan 1979
Decision
21d
Days
Class 1
Risk

K782112 is an FDA 510(k) clearance for the PADS, MINI, MAXI. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Intl. Playtex, Inc. (Walker, US). The FDA issued a Cleared decision on January 8, 1979 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 Intl. Playtex, Inc. devices

Submission Details

510(k) Number K782112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1978
Decision Date January 08, 1979
Days to Decision 21 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
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.