Chrysalis Intelligence · Product Codes · HEB

HEB · Tampon, Menstrual, Unscented

Obstetrics/Gynecology · 25 clearances · 15 unique sponsors

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Device class
Class II
Regulation 884.5470
Total clearances
25
2020-02-13 → 2026-03-20
Last 12 months
4
Unique sponsors
15
Definition

What is Tampon, Menstrual, Unscented

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.
Classification details
Medical specialty
Obstetrics/Gynecology
Review panel
OB
Regulation number
884.5470
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Unibeauty (Hubei) Technology Co., Ltd. 4 2 2025-12-17
Cotton High Tech S.L. 4 1 2025-10-09
Calla Lily Personal Care, Ltd. 3 0 2021-08-19
Dong-A Pharmaceutical Co., Ltd. 2 0 2022-04-21
Suzhou Borage Medical Technology Co., Ltd. 2 0 2024-05-10
Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. 1 0 2023-08-14
Kimberly-Clark Corporation 1 0 2023-01-06
Qingdao Youjia Hygiene Technology Co., Ltd. 1 0 2020-02-13
Liviwell, Inc. 1 1 2026-03-20
Tosama, D.O.O. 1 0 2024-04-12
Cycle, LLC 1 0 2021-08-13
Tampro, Inc. 1 0 2023-08-03
Annes Daye, Ltd. 1 0 2023-08-18
Essity Higiene Y Salud Mexico. S.A. DE C.V. 1 0 2025-04-01
Shandong Intco Hygiene Products Co., Ltd. 1 0 2025-01-10
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
A4539 HCPCS — High Hygienic pad, absorbent material; menstrual tampon
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-03-20 K252005 Liviwell, Inc. Livi Device
2025-12-17 K253719 Unibeauty (Hubei) Technology Co., Ltd. Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons
2025-10-09 K252939 Cotton High Tech S.L. COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
2025-09-19 K252613 Unibeauty (Hubei) Technology Co., Ltd. Unscented menstrual three-piece applicator tampon
2025-08-13 K251033 Unibeauty (Hubei) Technology Co., Ltd. Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons
2025-04-01 K242105 Essity Higiene Y Salud Mexico. S.A. DE C.V. SABA Tampons
2025-01-10 K241064 Shandong Intco Hygiene Products Co., Ltd. Unscented Tampon
2024-05-10 K240708 Suzhou Borage Medical Technology Co., Ltd. Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
2024-04-12 K232060 Tosama, D.O.O. TOSAMA Reusable Applicator
2023-12-15 K232598 Unibeauty (Hubei) Technology Co., Ltd. Unscented Menstrual Tampon
2023-08-18 K223883 Annes Daye, Ltd. Daye Tampon
2023-08-14 K231341 Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. Organic cotton tampon, Viscose tampon
2023-08-03 K230419 Tampro, Inc. Sequel Tampon with Plastic Applicator
2023-01-06 K223749 Kimberly-Clark Corporation U by Kotex® Click® Unscented Menstrual Tampons
2022-09-30 K222046 Suzhou Borage Medical Technology Co., Ltd. Unscented Menstrual Tampon
2022-04-21 K212277 Dong-A Pharmaceutical Co., Ltd. Tempo Tampon
2022-02-25 K220238 Cotton High Tech S.L. Cohitech Cottonlock Tampons with Reusable Applicator
2021-10-22 K211775 Cotton High Tech S.L. Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
2021-10-08 K212479 Cotton High Tech S.L. Cohitech Reusable Tampon Applicator
2021-09-17 K212272 Dong-A Pharmaceutical Co., Ltd. Tempo Natural Tampon
2021-08-19 K212304 Calla Lily Personal Care, Ltd. Callaly Tampliner (super plus absorbency)
2021-08-13 K211519 Cycle, LLC Every Cycle Reusable Tampon Applicator
2021-06-10 K211469 Calla Lily Personal Care, Ltd. Callaly Tampliner
2020-12-07 K201003 Calla Lily Personal Care, Ltd. Callaly Tampliner
2020-02-13 K192557 Qingdao Youjia Hygiene Technology Co., Ltd. Youjia Unscented Tampon with Plastic Applicators
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence