Cleared Traditional

K130609 - VEEDA 100% COTTON MENSTRUAL TAMPON

K130609 is an FDA 510(k) clearance for VEEDA 100% COTTON MENSTRUAL TAMPON, manufactured by Naturalena Brands, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HEB cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K130609 · Naturalena Brands, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
14d
Days
Class 2
Risk

K130609 is an FDA 510(k) clearance for the VEEDA 100% COTTON MENSTRUAL TAMPON. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Naturalena Brands, Inc. (San Mateo, US). The FDA issued a Cleared decision on March 21, 2013 after a review of 14 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K130609

510(k) Number K130609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2013
Decision Date March 21, 2013
Days to Decision 14 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d faster than avg
Panel avg: 161d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HEB Tampon, Menstrual, Unscented

All 174
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K130609.
ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
K132595 · Ontex Bvba · Apr 2014
TAMPAX M PLASTIC TAMPONS, UNSCENTED
K133244 · The Procter & Gamble Company · Jan 2014
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
K131543 · Procter & Gamble Co. · Jun 2013
ONTEX AND OTHER PROPRIETARY NAMES
K122603 · Ontex Bvba · Dec 2012
LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER, SUPER PLUS AND ULTRA LIL-LETS NON APPLICATOR,
K120481 · Tosama, D.O.O. · Jul 2012
TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED
K113699 · The Procter & Gamble Company · Jan 2012

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.