Cleared Traditional

K823241 - NEW FREEDOM THIN UNSCENTED MAXI PADS

K823241 is an FDA 510(k) clearance for NEW FREEDOM THIN UNSCENTED MAXI 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 57-day FDA review.

K823241 · Kimberly-Clark Corp. · Obstetrics & Gynecology device
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Dec 1982
Decision
57d
Days
Class 1
Risk

K823241 is an FDA 510(k) clearance for the NEW FREEDOM THIN UNSCENTED MAXI PADS. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Kimberly-Clark Corp. (Walker, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 57 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 Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K823241

510(k) Number K823241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1982
Decision Date December 28, 1982
Days to Decision 57 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 160d · This submission: 57d
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 K823241.
MODIFIED UNSCENTED MENSTRUAL PADS
K831707 · Personal Products Co. · Jun 1983
PANTY-LINERS UNSCENTED
K830145 · Procter & Gamble Mfg. Co. · Jan 1983
UNSCENTED MENSTRUAL PADS
K823477 · Procter & Gamble Mfg. Co. · Jan 1983
SURE & NATURAL MAXISHIELDS
K823239 · Personal Products Co. · Dec 1982
U.V.A.C. CURETTES
K822756 · American Hospital Supply Corp. · Sep 1982
CAREFREE PANTY SHIELDS
K820522 · Personal Products Co. · Mar 1982