Cleared Traditional

K102445 - ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS

K102445 is an FDA 510(k) clearance for ROSTAM SCENTED AND UNSCENTED BIODEGRADA..., manufactured by Rostam , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K102445 · Rostam , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
76d
Days
Class 2
Risk

K102445 is an FDA 510(k) clearance for the ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Rostam , Ltd. (Old Lyme, US). The FDA issued a Cleared decision on November 10, 2010 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5470 - 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.

FDA 510(k) Submission Details - K102445

510(k) Number K102445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2010
Decision Date November 10, 2010
Days to Decision 76 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
85d faster than avg
Panel avg: 161d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEB Device Classification - Class 2, Special Controls

Product Code HEB Tampon, Menstrual, Unscented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5470
Definition An Unscented 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 - HEB Tampon, Menstrual, Unscented

All 177
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K102445.
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
K112635 · Kimberly-Clark Corp. · Oct 2011
TAMPAX C PLASTIC TAMPONS, UNSCENTED
K110669 · The Procter & Gamble Co. · Jun 2011
U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS
K103311 · Kimberly Clark Corporation · Dec 2010
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
K091281 · Procter & Gamble Co. · Jun 2010
ONTEX TAMPON (UNSCENTED)
K090819 · Ontex International NV · Dec 2009
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
K091749 · Kimberly-Clark Corp. · Dec 2009
K102445 · ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS
Download PDF FDA Summary Rostam , Ltd.