Cleared Traditional

K920830 - NEW FREEDOM ULTRA THIN PADS

K920830 is an FDA 510(k) clearance for NEW FREEDOM ULTRA THIN PADS, manufactured by Kimberly-Clark Corp.. The device is a Class 1 Obstetrics & Gynecology device with product code HHD cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K920830 · Kimberly-Clark Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
193d
Days
Class 1
Risk

K920830 is an FDA 510(k) clearance for the NEW FREEDOM ULTRA THIN PADS. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Kimberly-Clark Corp. (Neenah, US). The FDA issued a Cleared decision on September 4, 1992 after a review of 193 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.

View all Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K920830

510(k) Number K920830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1992
Decision Date September 04, 1992
Days to Decision 193 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 160d · This submission: 193d
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 56
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K920830.
ENVIVE MINIFORMS
K003843 · Procter & Gamble Co. · Feb 2001
UNSCENTED INTERLABIAL MENSTRUAL PAD
K993870 · Procter & Gamble Co. · Jan 2000
KOTEX(R) SECUREHOLD SUPER CURVE/CURVED MAXI PADS
K925250 · Kimberly-Clark Corp. · Mar 1993
STAYFREE(TM) MAXI-PAD
K913747 · Personal Products Co. · Nov 1991
O. B. PACK III
K902273 · Customed, Inc. · Aug 1990
O. B. PACK I
K902271 · Customed, Inc. · Aug 1990