Cleared Special

K132819 - PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS (FDA 510(k) Clearance)

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

K132819 · Playtex Manufacturing, Inc. · Obstetrics & Gynecology device
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Oct 2013
Decision
30d
Days
Class 2
Risk

K132819 is an FDA 510(k) clearance for the PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS. Classified as Tampon, Menstrual, Scented, Scented-deodorized (product code HIL), Class II - Special Controls.

Submitted by Playtex Manufacturing, Inc. (Allendale, US). The FDA issued a Cleared decision on October 9, 2013 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5460 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Playtex Manufacturing, Inc. devices

Submission Details

510(k) Number K132819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2013
Decision Date October 09, 2013
Days to Decision 30 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d faster than avg
Panel avg: 160d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.