Cleared Traditional

K965064 - ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON

K965064 is an FDA 510(k) clearance for ROSTAM APPLICATOR TAMPON/ROSTAM NON APP..., 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 64-day FDA review.

K965064 · Rostam , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
64d
Days
Class 2
Risk

K965064 is an FDA 510(k) clearance for the ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Rostam , Ltd. (Greenfield, US). The FDA issued a Cleared decision on February 20, 1997 after a review of 64 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 - K965064

510(k) Number K965064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1996
Decision Date February 20, 1997
Days to Decision 64 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
96d faster than avg
Panel avg: 160d · This submission: 64d
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 122
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K965064.
FEMTEX 100% COTTON TAMPONS
K971228 · Regu-Tech Assoc., Inc. · Apr 1997
HARMONIES MENSTRUAL TAMPON
K970108 · Ecoprogress Intl. · Apr 1997
FEMTEX 100% COTTON DENTLE TOUCH TAMPONS
K970232 · Regu-Tech Assoc., Inc. · Mar 1997
UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR
K962476 · Tambrands, Inc. · Aug 1996
TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS
K960341 · Tambrands, Inc. · Apr 1996
PLAYTEX ULTIMATES SILK GLIDE TAMPONS #22894
K944064 · Playtex, Inc. · Feb 1995