Cleared Traditional

K862675 - MODIFIED DEODORANT MAXITHINS PANTY SHIELDS

K862675 is the FDA 510(k) clearance for MODIFIED DEODORANT MAXITHINS PANTY SHIELDS by Tambrands, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HHL) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K862675 · Tambrands, Inc. · Obstetrics & Gynecology device
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Aug 1986
Decision
35d
Days
Class 2
Risk

K862675 is an FDA 510(k) clearance for the MODIFIED DEODORANT MAXITHINS PANTY SHIELDS. Classified as Pad, Menstrual, Scented, Scented-deodorized (product code HHL), Class II - Special Controls.

Submitted by Tambrands, Inc. (Palmer, US). The FDA issued a Cleared decision on August 18, 1986 after a review of 35 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 Tambrands, Inc. devices

Submission Details

510(k) Number K862675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1986
Decision Date August 18, 1986
Days to Decision 35 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
125d faster than avg
Panel avg: 160d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K862675.
MAXITHINS PANTY SHIELDS, DEODORANT
K884445 · Tambrands, Inc. · Dec 1988
UNSCENTED MENSTRUAL PAD
K864673 · Procter & Gamble Mfg. Co. · Jan 1987
KOTEX (R) GOODNITES
K864187 · Kimberly-Clark Corp. · Dec 1986
MODIFIED SUPER DEODORANT MAXITHINS PADS
K862676 · Tambrands, Inc. · Aug 1986
MODIFIED REGULAR DEODORANT MAXITHINS PADS
K862678 · Tambrands, Inc. · Aug 1986
KOTEX LIGHTDAYS DEODORANT PANTILINERS
K862285 · Kimberly-Clark Corp. · Jul 1986