Cleared Traditional

K843958 - DEODORANT SUPER MAXITHINS BODY-SHAPED M...

K843958 is the FDA 510(k) clearance for DEODORANT SUPER MAXITHINS BODY-SHAPED M... by Tambrands, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HHL) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K843958 · Tambrands, Inc. · Obstetrics & Gynecology device
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Nov 1984
Decision
28d
Days
Class 2
Risk

K843958 is an FDA 510(k) clearance for the DEODORANT SUPER MAXITHINS BODY-SHAPED MAXI 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 November 7, 1984 after a review of 28 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 K843958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1984
Decision Date November 07, 1984
Days to Decision 28 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
132d faster than avg
Panel avg: 160d · This submission: 28d
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 K843958.
BELIEVE DEODORANT LABIAL PADS
K852225 · Kimberly-Clark Corp. · Aug 1985
ALWAYS SUPER MAXIPAD-SCENTED
K850939 · Procter & Gamble Mfg. Co. · May 1985
ALWAYS MAXIPADS - SCENTED
K850956 · Procter & Gamble Mfg. Co. · May 1985
DEODORANT REGULAR MAXITHINS BODY-SHAPED MAXI PADS
K843959 · Tambrands, Inc. · Nov 1984
DEODORANT MAXITHINS BODY-SHAPED PANTY SHIELDS
K843960 · Tambrands, Inc. · Nov 1984
SURE & NATURAL DEODORANT MAXI-SHIELD
K843155 · Johnson & Johnson Professionals, Inc. · Aug 1984