Cleared Traditional

K162746 - Ontex and other proprietary names

K162746 is an FDA 510(k) clearance for Ontex and other proprietary names, 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 154-day FDA review.

K162746 · Ontex Bvba · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
154d
Days
Class 2
Risk

K162746 is an FDA 510(k) clearance for the Ontex and other proprietary names. 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 March 3, 2017 after a review of 154 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 - K162746

510(k) Number K162746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2016
Decision Date March 03, 2017
Days to Decision 154 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
6d faster than avg
Panel avg: 160d · This submission: 154d
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 114
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K162746.
Interlude and private label Unscented 3-piece compact applicator tampon
K173225 · Albaad Fem · Jun 2018
Playtex Stella Tampons
K180167 · Playtex Manufacturing, Inc. · May 2018
Tosama Biobased Applicator Tube Menstrual Tampon
K172504 · Tosama, D.O.O. · Feb 2018
U BY KOTEX SECURITY UNSCENTED MENSTRUAL TAMPONS
K141294 · Kimberly-Clark Corp. · Aug 2014
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
K131543 · Procter & Gamble Co. · Jun 2013
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS
K112635 · Kimberly-Clark Corp. · Oct 2011