Cleared Traditional

K132595 - ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS

K132595 is an FDA 510(k) clearance for ONTEX ROLL WADDING PLASTIC APPLICATOR C..., manufactured by Ontex Bvba. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K132595 · Ontex Bvba · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
247d
Days
Class 2
Risk

K132595 is an FDA 510(k) clearance for the ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Ontex Bvba (The Hague, NL). The FDA issued a Cleared decision on April 23, 2014 after a review of 247 days - an extended review 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: 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.

View all Ontex Bvba devices

FDA 510(k) Submission Details - K132595

510(k) Number K132595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2013
Decision Date April 23, 2014
Days to Decision 247 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
87d slower than avg
Panel avg: 160d · This submission: 247d
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 153
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K132595.
Tosama 100% Cotton Menstrual Tampon
K150897 · Tosama, D.O.O. · Apr 2015
ALBAAD PLASTIC APPLICATOR TAMPONS UNSCENTED
K140077 · Albaad , Ltd. · Sep 2014
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
K141294 · Kimberly-Clark Corp. · Aug 2014
TAMPAX M PLASTIC TAMPONS, UNSCENTED
K133244 · The Procter & Gamble Company · Jan 2014
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
K131543 · Procter & Gamble Co. · Jun 2013
VEEDA 100% COTTON MENSTRUAL TAMPON
K130609 · Naturalena Brands, Inc. · Mar 2013