Cleared Traditional

K151413 - Always/Tampax bladder supports

K151413 is an FDA 510(k) clearance for Always/Tampax bladder supports, manufactured by Procter & Gamble. The device is a Class 2 Obstetrics & Gynecology device with product code HHW cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K151413 · Procter & Gamble · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
205d
Days
Class 2
Risk

K151413 is an FDA 510(k) clearance for the Always/Tampax bladder supports. Classified as Pessary, Vaginal (product code HHW), Class II - Special Controls.

Submitted by Procter & Gamble (Cincinnati, US). The FDA issued a Cleared decision on December 18, 2015 after a review of 205 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.3575 - 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 - K151413

510(k) Number K151413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2015
Decision Date December 18, 2015
Days to Decision 205 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
44d slower than avg
Panel avg: 161d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

HHW Device Classification - Class 2, Special Controls

Product Code HHW Pessary, Vaginal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.3575
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01762345 Completed Interventional Industry-sponsored

A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence

148
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Stress Urinary Incontinence
Study design Single group
Eligibility Female only · 18 Years+
Principal investigator Randall Severance, MD
Sponsor Procter and Gamble (industry)
Started 2012-12-01 → Primary completion 2013-07-01
Primary outcome
Change in Pad Weight Gain
Secondary outcome
Change in Pad Weight Gain
View full study on ClinicalTrials.gov

Regulatory Peers - HHW Pessary, Vaginal

All 38
Devices cleared under the same product code (HHW) and FDA review panel - the closest regulatory comparables to K151413.
Revive Reusable Bladder Support
K183468 · Rinovum Subsidiary 2, LLC · Jan 2019
Panpac Flexi Shelf Pessary
K173351 · Panpac Medical Corporation · Oct 2018
Panpac Disposable Pessary Fitting Set
K153422 · Panpac Medical Corporation · Jul 2016
PESSARY
K132313 · Eis Corporation · Dec 2014
PANPAC INFLATABLE DOCUT PESSARY
K132670 · Panpac Medical Corporation · Jun 2014
TIPI OTC
K131198 · Contipi , Ltd. · Aug 2013
K151413 · Always/Tampax bladder supports
Download PDF FDA Summary Procter & Gamble