Cleared Traditional

K862270 - LAURIER OVERNIGHT SANITARY NAPKIN (MODI...

K862270 is the FDA 510(k) clearance for LAURIER OVERNIGHT SANITARY NAPKIN (MODI... by Kao Corp.. It is a Class 1 Obstetrics & Gynecology device (product code HHD) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K862270 · Kao Corp. · Obstetrics & Gynecology device
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Jul 1986
Decision
24d
Days
Class 1
Risk

K862270 is an FDA 510(k) clearance for the LAURIER OVERNIGHT SANITARY NAPKIN (MODIFICATION). Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Kao Corp. (Tokyo 103 Japan, JP). The FDA issued a Cleared decision on July 7, 1986 after a review of 24 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 Kao Corp. devices

Submission Details

510(k) Number K862270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1986
Decision Date July 07, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
136d faster than avg
Panel avg: 160d · This submission: 24d
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.

Regulatory Peers - HHD Pad, Menstrual, Unscented

All 54
Devices cleared under the same product code (HHD) and FDA review panel - the closest regulatory comparables to K862270.
MODIFIED MAXITHINS PANTY SHIELDS UNSCENTED
K862677 · Tambrands, Inc. · Aug 1986
MODIFIED SUPER MAXITHINS PADS, UNSCENTED
K862679 · Tambrands, Inc. · Aug 1986
MODIFIED REGULAR MAXITHINS PADS, UNSCENTED
K862680 · Tambrands, Inc. · Aug 1986
KOTEX PROFILE SHAPED MAXI PAD
K861902 · Kimberly-Clark Corp. · Jun 1986
KOTEX OVERNITE
K860587 · Kimberly-Clark Corp. · Mar 1986
BELIEVE HEAVY FLOW PROTECTION LABIAL PADS
K853630 · Kimberly-Clark Corp. · Nov 1985