Cleared Traditional

K011996 - TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS

K011996 is an FDA 510(k) clearance for TAMPAX PEARL SCENTED AND UNSCENTED TAMP..., manufactured by Procter & Gamble Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HIL cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K011996 · Procter & Gamble Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
84d
Days
Class 2
Risk

K011996 is an FDA 510(k) clearance for the TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Procter & Gamble Co. (Cincinnati, US). The FDA issued a Cleared decision on September 19, 2001 after a review of 84 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 Procter & Gamble Co. devices

FDA 510(k) Submission Details - K011996

510(k) Number K011996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2001
Decision Date September 19, 2001
Days to Decision 84 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 160d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIL Device Classification - Class 2, Special Controls

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 68
Devices cleared under the same product code (HIL) and FDA review panel - the closest regulatory comparables to K011996.
PLAYTEX DEODORANT TAMPONS, MODEL 34802
K020200 · Playtex Products, Inc. · Mar 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34902
K020201 · Playtex Products, Inc. · Mar 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34702
K020202 · Playtex Products, Inc. · Mar 2002
TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS
K011171 · Procter & Gamble Co. · Jul 2001
PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES TAMPONS
K982383 · Playtex Products, Inc. · Aug 1998
PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS
K971547 · Playtex Products, Inc. · Jun 1997