Cleared Traditional

K032080 - ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS

K032080 is an FDA 510(k) clearance for ROSTAM LTD FRAGRANCED PLASTIC APPLICATO..., manufactured by Rostam , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HIL cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K032080 · Rostam , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
38d
Days
Class 2
Risk

K032080 is an FDA 510(k) clearance for the ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Rostam , Ltd. (Allendale, US). The FDA issued a Cleared decision on August 14, 2003 after a review of 38 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 Rostam , Ltd. devices

FDA 510(k) Submission Details - K032080

510(k) Number K032080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2003
Decision Date August 14, 2003
Days to Decision 38 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 160d · This submission: 38d
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 67
Devices cleared under the same product code (HIL) and FDA review panel - the closest regulatory comparables to K032080.
MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
K070745 · Playtex Products, Inc. · Apr 2007
PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
K060981 · Playtex Products, Inc. · May 2006
TAMPAX PEARL SCENTED TAMPONS-JUNIOR, REGULAR, SUPER & SUPER PLUS
K040312 · Procter & Gamble Co. · May 2004
MODIFICATION TO PLAYTEX TAMPONS #24002
K022882 · Playtex Products, Inc. · Sep 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34802
K020200 · Playtex Products, Inc. · Mar 2002
PLAYTEX DEODORANT TAMPONS, MODEL 34902
K020201 · Playtex Products, Inc. · Mar 2002