Cleared Traditional

PADS MENSTRUAL, UNTREAT DEODORIZED, VARIOUS SIZES (K933879) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K933879 · Universal Health Care Products Canada, Inc. · Obstetrics & Gynecology device
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Mar 1994
Decision
227d
Days
Class 1
Risk

K933879 is an FDA 510(k) clearance for the PADS MENSTRUAL, UNTREAT DEODORIZED, VARIOUS SIZES. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Universal Health Care Products Canada, Inc. (Quebec H9r 3s4, CA). The FDA issued a Cleared decision on March 24, 1994 after a review of 227 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K933879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1993
Decision Date March 24, 1994
Days to Decision 227 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 160d · This submission: 227d
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.