Cleared Traditional

K853630 - BELIEVE HEAVY FLOW PROTECTION LABIAL PADS

K853630 is an FDA 510(k) clearance for BELIEVE HEAVY FLOW PROTECTION LABIAL 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 69-day FDA review.

K853630 · Kimberly-Clark Corp. · Obstetrics & Gynecology device
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Nov 1985
Decision
69d
Days
Class 1
Risk

K853630 is an FDA 510(k) clearance for the BELIEVE HEAVY FLOW PROTECTION LABIAL PADS. Classified as Pad, Menstrual, Unscented (product code HHD), Class I - General Controls.

Submitted by Kimberly-Clark Corp. (Neenah, US). The FDA issued a Cleared decision on November 7, 1985 after a review of 69 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 - K853630

510(k) Number K853630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1985
Decision Date November 07, 1985
Days to Decision 69 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
91d faster than avg
Panel avg: 160d · This submission: 69d
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 K853630.
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
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