Cleared Traditional

K882364 - KOTEX LIGHTDAYS LONGS DEODORANT & REG. ...

K882364 is an FDA 510(k) clearance for KOTEX LIGHTDAYS LONGS DEODORANT & REG. ..., 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 55-day FDA review.

K882364 · Kimberly-Clark Corp. · Obstetrics & Gynecology device
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Aug 1988
Decision
55d
Days
Class 1
Risk

K882364 is an FDA 510(k) clearance for the KOTEX LIGHTDAYS LONGS DEODORANT & REG. PANTILINERS. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Kimberly-Clark Corp. (Washington, US). The FDA issued a Cleared decision on August 2, 1988 after a review of 55 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 - K882364

510(k) Number K882364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1988
Decision Date August 02, 1988
Days to Decision 55 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
105d faster than avg
Panel avg: 160d · This submission: 55d
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 K882364.
TAMPAX ULTRAFIT PANTY SHIELDS - MOFIFICATION
K891474 · Tambrands, Inc. · Jun 1989
NEW FREEDOM THIN SUPER & UNSCENTED, MAXI & SUPER
K890654 · Kimberly-Clark Corp. · Apr 1989
TAMPAX ULTRAFIT PANTY SHIELDS
K884950 · Tambrands, Inc. · Jan 1989
UNSCENTED MENSTRUAL PADS
K880735 · Personal Products Co. · Apr 1988
ULTRA MAXITHINS PADS
K871716 · Tambrands, Inc. · Jun 1987
KOTEX PROFILE SHAPED MAXI PAD
K871210 · Kimberly-Clark Corp. · Apr 1987