Cleared Traditional

K142786 - Ontex Unscented Tampons with Colored Plastic Applicators

K142786 is an FDA 510(k) clearance for Ontex Unscented Tampons with Colored Pl..., 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 270-day FDA review.

K142786 · Ontex Bvba · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
270d
Days
Class 2
Risk

K142786 is an FDA 510(k) clearance for the Ontex Unscented Tampons with Colored Plastic Applicators. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Ontex Bvba (Buggenhout Oost - Vlaanderen, BE). The FDA issued a Cleared decision on June 23, 2015 after a review of 270 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 - K142786

510(k) Number K142786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2014
Decision Date June 23, 2015
Days to Decision 270 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
110d slower than avg
Panel avg: 160d · This submission: 270d
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 Consultant

Emergo Europe Consulting
Rachel Paul

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K142786.
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS
K152284 · Cotton High Tech S.L. · Dec 2015
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
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