Cleared Traditional

K152284 - COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS

Also marketed or referenced as:
COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS

K152284 is an FDA 510(k) clearance for COHITECH NON APPLICATOR ORGANIC COTTON ..., 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 114-day FDA review.

K152284 · Cotton High Tech S.L. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
114d
Days
Class 2
Risk

K152284 is an FDA 510(k) clearance for the COHITECH NON APPLICATOR ORGANIC COTTON 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 December 4, 2015 after a review of 114 days - within the typical 510(k) review window.

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: 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.

View all Cotton High Tech S.L. devices

FDA 510(k) Submission Details - K152284

510(k) Number K152284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2015
Decision Date December 04, 2015
Days to Decision 114 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
47d faster than avg
Panel avg: 161d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - HEB Tampon, Menstrual, Unscented

All 166
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K152284.
U by Kotex Click Unscented Menstrual Tampons
K172118 · Kimberly Clark Corporation · Oct 2017
Ontex and other proprietary names
K162746 · Ontex Bvba · Mar 2017
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl
K161877 · First Quality Hygienic, Inc. · Aug 2016
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency
K151470 · First Quality Hygienic, Inc. · Nov 2015
Tosama 100% Organic Cotton Menstrual Tampon
K151170 · Tosama, D.O.O. · Jul 2015
Ontex Unscented Tampons with Colored Plastic Applicators
K142786 · Ontex Bvba · Jun 2015