Cleared Traditional

K001641 - TAMPONS

K001641 is an FDA 510(k) clearance for TAMPONS, 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 65-day FDA review.

K001641 · Rostam , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
65d
Days
Class 2
Risk

K001641 is an FDA 510(k) clearance for the TAMPONS. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Rostam , Ltd. (Allendale, US). The FDA issued a Cleared decision on August 3, 2000 after a review of 65 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.

View all Rostam , Ltd. devices

FDA 510(k) Submission Details - K001641

510(k) Number K001641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2000
Decision Date August 03, 2000
Days to Decision 65 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
95d faster than avg
Panel avg: 160d · This submission: 65d
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 123
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K001641.
TAMPAX TAMPONS (JUNIOR, REGULAR, SUPER AND SUPER PLUS ABSORBENCIES)
K040999 · Procter & Gamble Co. · Jul 2004
PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)
K032636 · Playtex Products, Inc. · Nov 2003
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR
K002096 · Procter & Gamble Co. · Sep 2000
O.B. TAMPON
K990536 · Personal Products Co. · Aug 1999
O.B. APPLICATOR TAMPONS, O.B. TAMPONS
K991118 · Personal Products Co. · Jun 1999
PLAYTEX TAMPONS #03498
K980478 · Playtex, Inc. · Apr 1998