Cleared Traditional

K880024 - TAMPAX COMPAK

K880024 is the FDA 510(k) clearance for TAMPAX COMPAK by Tambrands, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIL) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K880024 · Tambrands, Inc. · Obstetrics & Gynecology device
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Mar 1988
Decision
63d
Days
Class 2
Risk

K880024 is an FDA 510(k) clearance for the TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER PLUS. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Tambrands, Inc. (Palmer, US). The FDA issued a Cleared decision on March 8, 1988 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5460 - 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 K880024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1988
Decision Date March 08, 1988
Days to Decision 63 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
97d faster than avg
Panel avg: 160d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIL Tampon, Menstrual, Scented, Scented-deodorized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5460
Definition A Scented Or Scented-deodorized Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.
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 - HIL Tampon, Menstrual, Scented, Scented-deodorized

All 23
Devices cleared under the same product code (HIL) and FDA review panel - the closest regulatory comparables to K880024.
O.B. APPLICATOR TAMPONS
K953638 · Personal Products Co. · Oct 1995
SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS
K952344 · Tambrands, Inc. · Jul 1995
TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER
K896115 · Tambrands, Inc. · Dec 1989
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON
K880022 · Tambrands, Inc. · Mar 1988
TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON
K880023 · Tambrands, Inc. · Mar 1988
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
K873457 · Procter & Gamble Mfg. Co. · Jan 1988