Cleared Abbreviated

ONTEX TAMPON (UNSCENTED) (K090819) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K090819 · Ontex International NV · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
273d
Days
Class 2
Risk

K090819 is an FDA 510(k) clearance for the ONTEX TAMPON (UNSCENTED). Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Ontex International NV (Austin, US). The FDA issued a Cleared decision on December 23, 2009 after a review of 273 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ontex International NV devices

Submission Details

510(k) Number K090819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2009
Decision Date December 23, 2009
Days to Decision 273 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 160d · This submission: 273d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 188
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K090819.
Livi Device
K252005 · Liviwell, Inc. · Mar 2026
Unscented Menstrual Long Applicator Tampon
K253719 · Unibeauty (Hubei) Technology Co., Ltd. · Dec 2025
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
K252939 · Cotton High Tech S.L. · Oct 2025
Unscented menstrual three-piece applicator tampon
K252613 · Unibeauty (Hubei) Technology Co., Ltd. · Sep 2025
Unscented menstrual long applicator tampon
K251033 · Unibeauty (Hubei) Technology Co., Ltd. · Aug 2025
SABA Tampons
K242105 · Essity Higiene Y Salud Mexico. S.A. DE C.V. · Apr 2025