Cleared Traditional

Cohitech Organic Cotton Non-Applicator Cottonlock Tampons (K211775) - FDA 510(k) Clearance

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

K211775 · Cotton High Tech S.L. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
135d
Days
Class 2
Risk

K211775 is an FDA 510(k) clearance for the Cohitech Organic Cotton Non-Applicator Cottonlock 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 22, 2021 after a review of 135 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

Submission Details

510(k) Number K211775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2021
Decision Date October 22, 2021
Days to Decision 135 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
25d faster than avg
Panel avg: 160d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 37
Devices cleared under the same product code (HEB) and FDA review panel - the closest regulatory comparables to K211775.
Unscented Menstrual Tampon
K222046 · Suzhou Borage Medical Technology Co., Ltd. · Sep 2022
Tempo Tampon
K212277 · Dong-A Pharmaceutical Co., Ltd. · Apr 2022
Cohitech Cottonlock Tampons with Reusable Applicator
K220238 · Cotton High Tech S.L. · Feb 2022
Cohitech Reusable Tampon Applicator
K212479 · Cotton High Tech S.L. · Oct 2021
Tempo Natural Tampon
K212272 · Dong-A Pharmaceutical Co., Ltd. · Sep 2021
Callaly Tampliner (super plus absorbency)
K212304 · Calla Lily Personal Care, Ltd. · Aug 2021