Cleared Traditional

K091084 - MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS

K091084 is an FDA 510(k) clearance for MAXIM MENSTRUAL TAMPONS & ORGANYC MENST..., manufactured by Cotton High Tech S.L.. 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.

K091084 · Cotton High Tech S.L. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
14d
Days
Class 2
Risk

K091084 is an FDA 510(k) clearance for the MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Cotton High Tech S.L. (Barcelona, ES). The FDA issued a Cleared decision on April 29, 2009 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.

View all Cotton High Tech S.L. devices

FDA 510(k) Submission Details - K091084

510(k) Number K091084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2009
Decision Date April 29, 2009
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.
CASEY CONRY

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 166
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K091084.
U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS
K091749 · Kimberly-Clark Corp. · Dec 2009
MOXIE PLASTIC APPLICATOR AND MOXIE NON-APPLICATOR TAMPON
K092054 · Tosama D.D. · Jul 2009
ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS
K090071 · Rostam , Ltd. · May 2009
COTTONS 100% NATURAL COTTON TAMPONS
K080733 · Cottons Pty, Ltd. · Feb 2009
MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON
K090098 · Maxim Hygiene Products, Inc. · Jan 2009
MAXIM PLASTIC APPLICATOR & NON-APPLICATOR TAMPONS
K080775 · Tosama D.D. · Sep 2008

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.