Cleared Traditional

Cohitech Reusable Tampon Applicator (K212479) - FDA 510(k) Clearance

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

K212479 · Cotton High Tech S.L. · Obstetrics & Gynecology device
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Oct 2021
Decision
60d
Days
Class 2
Risk

K212479 is an FDA 510(k) clearance for the Cohitech Reusable Tampon Applicator. 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 8, 2021 after a review of 60 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 K212479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2021
Decision Date October 08, 2021
Days to Decision 60 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
100d faster than avg
Panel avg: 160d · This submission: 60d
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 K212479.
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 Organic Cotton Non-Applicator Cottonlock Tampons
K211775 · 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
Every Cycle Reusable Tampon Applicator
K211519 · Cycle, LLC · Aug 2021