Cleared Special

K252613 - Unscented menstrual three-piece applicator tampon (FDA 510(k) Clearance)

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

K252613 · Unibeauty (Hubei) Technology Co., Ltd. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Sep 2025
Decision
31d
Days
Class 2
Risk

K252613 is an FDA 510(k) clearance for the Unscented menstrual three-piece applicator tampon. Classified as Tampon, Menstrual, Unscented (product code HEB), Class II - Special Controls.

Submitted by Unibeauty (Hubei) Technology Co., Ltd. (Xiantao, CN). The FDA issued a Cleared decision on September 19, 2025 after a review of 31 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 Unibeauty (Hubei) Technology Co., Ltd. devices

Submission Details

510(k) Number K252613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2025
Decision Date September 19, 2025
Days to Decision 31 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
129d faster than avg
Panel avg: 160d · This submission: 31d
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 Consultant

Shanghai Jiushun Enterprise Management Technology Service
Doris Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K252613.
Livi Device
K252005 · Liviwell, Inc. · Mar 2026
Unscented Menstrual Long Applicator Tampon
K253719 · Unibeauty (Hubei) Technology Co., Ltd. · Dec 2025
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
K252939 · Cotton High Tech S.L. · Oct 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