Cleared Special

K252939 - COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (FDA 510(k) Clearance)

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

K252939 · Cotton High Tech S.L. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
24d
Days
Class 2
Risk

K252939 is an FDA 510(k) clearance for the COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Cotton High Tech S.L. (Balsareny, ES). The FDA issued a Cleared decision on October 9, 2025 after a review of 24 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. 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 Cotton High Tech S.L. devices

Submission Details

510(k) Number K252939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2025
Decision Date October 09, 2025
Days to Decision 24 days
Submission Type Special
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
136d faster than avg
Panel avg: 160d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 K252939.
Livi Device
K252005 · Liviwell, Inc. · Mar 2026
Unscented Menstrual Long Applicator Tampon
K253719 · Unibeauty (Hubei) Technology Co., Ltd. · Dec 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
Unscented Tampon
K241064 · Shandong Intco Hygiene Products Co., Ltd. · Jan 2025