Cleared Traditional

K850033 - KOTEX MAXI PADS

K850033 is an FDA 510(k) clearance for KOTEX 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.

K850033 · Kimberly-Clark Corp. · Obstetrics & Gynecology device
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Mar 1985
Decision
57d
Days
Class 1
Risk

K850033 is an FDA 510(k) clearance for the KOTEX MAXI PADS. 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 March 1, 1985 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 - K850033

510(k) Number K850033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1985
Decision Date March 01, 1985
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 K850033.
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
KOTEX THIN MAXI PADS
K850034 · Kimberly-Clark Corp. · Mar 1985
UNSCENTED MENSTRUAL PAD
K844601 · Procter & Gamble Mfg. Co. · Jan 1985
SCENTED MENSTRUAL PAD
K844602 · Procter & Gamble Mfg. Co. · Jan 1985