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) Official FDA 510(k) Summary (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.

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
7d faster than avg
Panel avg: 161d · 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 177
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K162746.
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 Click Unscented Menstrual Tampons
K172118 · Kimberly Clark Corporation · Oct 2017
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl
K161877 · First Quality Hygienic, Inc. · Aug 2016
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
K162746 · Ontex and other proprietary names
Download PDF FDA Summary Ontex Bvba