Cleared Traditional

K090071 - ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS

K090071 is an FDA 510(k) clearance for ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED ..., 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 136-day FDA review.

K090071 · Rostam , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
136d
Days
Class 2
Risk

K090071 is an FDA 510(k) clearance for the ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW 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 May 28, 2009 after a review of 136 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K090071

510(k) Number K090071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2009
Decision Date May 28, 2009
Days to Decision 136 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
25d faster than avg
Panel avg: 161d · This submission: 136d
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 K090071.
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
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
K092054 · Tosama D.D. · Jul 2009
MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS
K091084 · Cotton High Tech S.L. · Apr 2009
COTTONS 100% NATURAL COTTON TAMPONS
K080733 · Cottons Pty, Ltd. · Feb 2009
MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON
K090098 · Maxim Hygiene Products, Inc. · Jan 2009
K090071 · ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
Download PDF FDA Summary Rostam , Ltd.