Cleared Traditional

K852922 - LAURIER OVERNIGHT SANITARY NAPKIN

K852922 is the FDA 510(k) clearance for LAURIER OVERNIGHT SANITARY NAPKIN by Kao Corp.. It is a Class 1 Obstetrics & Gynecology device (product code HHD) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K852922 · Kao Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1985
Decision
48d
Days
Class 1
Risk

K852922 is an FDA 510(k) clearance for the LAURIER OVERNIGHT SANITARY NAPKIN. 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 August 26, 1985 after a review of 48 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 K852922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1985
Decision Date August 26, 1985
Days to Decision 48 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
112d faster than avg
Panel avg: 160d · This submission: 48d
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 K852922.
KOTEX OVERNITE
K860587 · Kimberly-Clark Corp. · Mar 1986
BELIEVE HEAVY FLOW PROTECTION LABIAL PADS
K853630 · Kimberly-Clark Corp. · Nov 1985
UNSCENTED ALWAYS PANTILINERS
K852985 · Procter & Gamble Mfg. Co. · Aug 1985
BELIEVE LABIAL PADS
K852226 · Kimberly-Clark Corp. · Aug 1985
ALWAYS SUPER MAXIPAD-UNSCENTED
K850940 · Procter & Gamble Mfg. Co. · May 1985
ALWAYS MAXIPADS - UNSCENTED
K850955 · Procter & Gamble Mfg. Co. · May 1985