Cleared Traditional

K091084 - MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091084 · Cotton High Tech S.L. · Obstetrics & Gynecology device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
146d faster than avg
Panel avg: 160d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Peers - HEB Tampon, Menstrual, Unscented

All 188
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K091084.
Livi Device
K252005 · Liviwell, Inc. · Mar 2026
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K253719 · Unibeauty (Hubei) Technology Co., Ltd. · Dec 2025
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K252939 · Cotton High Tech S.L. · Oct 2025
Unscented menstrual three-piece applicator tampon
K252613 · Unibeauty (Hubei) Technology Co., Ltd. · Sep 2025
Unscented menstrual long applicator tampon
K251033 · Unibeauty (Hubei) Technology Co., Ltd. · Aug 2025
SABA Tampons
K242105 · Essity Higiene Y Salud Mexico. S.A. DE C.V. · Apr 2025