Cleared Traditional

K864187 - KOTEX GOODNITES

K864187 is an FDA 510(k) clearance for KOTEX GOODNITES, manufactured by Kimberly-Clark Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HHL cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K864187 · Kimberly-Clark Corp. · Obstetrics & Gynecology device
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Dec 1986
Decision
45d
Days
Class 2
Risk

K864187 is an FDA 510(k) clearance for the KOTEX (R) GOODNITES. Classified as Pad, Menstrual, Scented, Scented-deodorized (product code HHL), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Washington, US). The FDA issued a Cleared decision on December 11, 1986 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5425 - 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 - K864187

510(k) Number K864187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1986
Decision Date December 11, 1986
Days to Decision 45 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
115d faster than avg
Panel avg: 160d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHL Device Classification - Class 2, Special Controls

Product Code HHL Pad, Menstrual, Scented, Scented-deodorized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5425
Definition Scented Or Scented-deodorized Menstrual Pads Used To Absorb Menstrual Or Other Vaginal Discharge, Including Those Intended As Intralabial Pads Or Reusable Menstrual Pads. These Are Made With Materials That Do Not Meet The Requirements For Class 1 Per 21 Cfr 884.5425(b).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HHL Pad, Menstrual, Scented, Scented-deodorized

All 37
Devices cleared under the same product code (HHL) and FDA review panel - the closest regulatory comparables to K864187.
MAXITHINS REGULAR PADS, DEODORANT
K884444 · Tambrands, Inc. · Dec 1988
MAXITHINS PANTY SHIELDS, DEODORANT
K884445 · Tambrands, Inc. · Dec 1988
UNSCENTED MENSTRUAL PAD
K864673 · Procter & Gamble Mfg. Co. · Jan 1987
MODIFIED DEODORANT MAXITHINS PANTY SHIELDS
K862675 · Tambrands, Inc. · Aug 1986
MODIFIED SUPER DEODORANT MAXITHINS PADS
K862676 · Tambrands, Inc. · Aug 1986
MODIFIED REGULAR DEODORANT MAXITHINS PADS
K862678 · Tambrands, Inc. · Aug 1986