Cleared Traditional

K924176 - SABA INTIMA

K924176 is an FDA 510(k) clearance for SABA INTIMA, manufactured by Scott Paper Co.. The device is a Class 1 Obstetrics & Gynecology device with product code HHD cleared through the Traditional 510(k) pathway after a 491-day FDA review.

K924176 · Scott Paper Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
491d
Days
Class 1
Risk

K924176 is an FDA 510(k) clearance for the SABA INTIMA. 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

FDA 510(k) Submission Details - K924176

510(k) Number K924176 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.

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 64
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K924176.
ENVIVE MINIFORMS
K003843 · Procter & Gamble Co. · Feb 2001
UNSCENTED INTERLABIAL MENSTRUAL PAD
K993870 · Procter & Gamble Co. · Jan 2000
GLADRAGS COTTON MENSTRUAL PAD
K980395 · Keepers!, Inc. · Apr 1998
KOTEX(R) SECUREHOLD SUPER CURVE/CURVED MAXI PADS
K925250 · Kimberly-Clark Corp. · Mar 1993
ALWAYS CONTOURS UNSCENTED MENSTRUAL PADS
K922575 · Procter & Gamble Co. · Feb 1993
NEW FREEDOM ULTRA THIN PADS
K920830 · Kimberly-Clark Corp. · Sep 1992