Cleared Traditional

K150897 - Tosama 100% Cotton Menstrual Tampon

K150897 is an FDA 510(k) clearance for Tosama 100% Cotton Menstrual Tampon, manufactured by Tosama, D.O.O.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K150897 · Tosama, D.O.O. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
18d
Days
Class 2
Risk

K150897 is an FDA 510(k) clearance for the Tosama 100% Cotton Menstrual Tampon. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Tosama, D.O.O. (Vir, Domzale, SI). The FDA issued a Cleared decision on April 20, 2015 after a review of 18 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 Tosama, D.O.O. devices

FDA 510(k) Submission Details - K150897

510(k) Number K150897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2015
Decision Date April 20, 2015
Days to Decision 18 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
143d faster than avg
Panel avg: 161d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 166
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K150897.
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency
K151470 · First Quality Hygienic, Inc. · Nov 2015
Tosama 100% Organic Cotton Menstrual Tampon
K151170 · Tosama, D.O.O. · Jul 2015
Ontex Unscented Tampons with Colored Plastic Applicators
K142786 · Ontex Bvba · Jun 2015
ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED
K140077 · Albaad , Ltd. · Sep 2014
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
K141294 · Kimberly-Clark Corp. · Aug 2014
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
K132595 · Ontex Bvba · Apr 2014