Cleared Traditional

K862678 - MODIFIED REGULAR DEODORANT MAXITHINS PADS

K862678 is the FDA 510(k) clearance for MODIFIED REGULAR DEODORANT MAXITHINS PADS by Tambrands, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HHL) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K862678 · Tambrands, Inc. · Obstetrics & Gynecology device
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Aug 1986
Decision
32d
Days
Class 2
Risk

K862678 is an FDA 510(k) clearance for the MODIFIED REGULAR DEODORANT MAXITHINS PADS. 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 15, 1986 after a review of 32 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 K862678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1986
Decision Date August 15, 1986
Days to Decision 32 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
128d faster than avg
Panel avg: 160d · This submission: 32d
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 K862678.
KOTEX (R) GOODNITES
K864187 · Kimberly-Clark Corp. · Dec 1986
MODIFIED DEODORANT MAXITHINS PANTY SHIELDS
K862675 · Tambrands, Inc. · Aug 1986
MODIFIED SUPER DEODORANT MAXITHINS PADS
K862676 · Tambrands, Inc. · Aug 1986
KOTEX LIGHTDAYS DEODORANT PANTILINERS
K862285 · Kimberly-Clark Corp. · Jul 1986
SCENTED ALWAYS PANTILINERS
K853000 · Procter & Gamble Mfg. Co. · Sep 1985
BELIEVE DEODORANT LABIAL PADS
K852225 · Kimberly-Clark Corp. · Aug 1985