Cleared Special

K251033 - Unscented menstrual long applicator tampon (FDA 510(k) Clearance)

Also includes:
Unscented menstrual Compact Applicator Tampon Unscented menstrual Cardboard Applicator Tampon Unscented menstrual Digital Tampons

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

K251033 · Unibeauty (Hubei) Technology Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
132d
Days
Class 2
Risk

K251033 is an FDA 510(k) clearance for the Unscented menstrual long 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 August 13, 2025 after a review of 132 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. 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. Standard predicate reliance. 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 K251033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2025
Decision Date August 13, 2025
Days to Decision 132 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
28d faster than avg
Panel avg: 160d · This submission: 132d
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 Tech Service Co., Ltd.
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 K251033.
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 three-piece applicator tampon
K252613 · Unibeauty (Hubei) Technology Co., Ltd. · Sep 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