Cleared Traditional

K132208 - ONTEX AND OTHERS PROPRIETARY NAMES

K132208 is an FDA 510(k) clearance for ONTEX AND OTHERS PROPRIETARY NAMES, manufactured by Ontex Bvba. The device is a Class 2 Obstetrics & Gynecology device with product code HIL cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K132208 · Ontex Bvba · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
268d
Days
Class 2
Risk

K132208 is an FDA 510(k) clearance for the ONTEX AND OTHERS PROPRIETARY NAMES. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Ontex Bvba (The Hague, NL). The FDA issued a Cleared decision on April 10, 2014 after a review of 268 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5460 - 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 - K132208

510(k) Number K132208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2013
Decision Date April 10, 2014
Days to Decision 268 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
107d slower than avg
Panel avg: 161d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIL Device Classification - Class 2, Special Controls

Product Code HIL Tampon, Menstrual, Scented, Scented-deodorized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5460
Definition A Scented Or Scented-deodorized 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 - HIL Tampon, Menstrual, Scented, Scented-deodorized

All 77
Devices cleared under the same product code (HIL) and FDA review panel - the closest regulatory comparables to K132208.
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
K132819 · Playtex Manufacturing, Inc. · Oct 2013
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
K120245 · Playtex, Inc. · Jun 2012
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
K111684 · Playtex Manufacturing, Inc. · Feb 2012
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
K081555 · Procter & Gamble Co. · Jun 2008
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
K073662 · Playtex Products, Inc. · Jan 2008
PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONS
K072376 · Playtex Products, Inc. · Dec 2007