Cleared Traditional

SABA CONFORT (K924175) - FDA 510(k) Clearance

Class I Obstetrics & Gynecology device.

K924175 · Scott Paper Co. · Obstetrics & Gynecology device
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Dec 1993
Decision
491d
Days
Class 1
Risk

K924175 is an FDA 510(k) clearance for the SABA CONFORT. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Scott Paper Co. (Philadelphia, US). The FDA issued a Cleared decision on December 23, 1993 after a review of 491 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Scott Paper Co. devices

Submission Details

510(k) Number K924175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1992
Decision Date December 23, 1993
Days to Decision 491 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
331d slower than avg
Panel avg: 160d · This submission: 491d
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.