FDA Product Code HEB: 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.
Leading manufacturers include Cotton High Tech S.L., Unibeauty (Hubei) Technology Co., Ltd. and Albaad Fem.
189
Total
189
Cleared
114d
Avg days
1978
Since
Stable submission activity - 7 submissions in the last 2 years
Review times increasing: avg
143d
recently vs 113d historically
FDA 510(k) Cleared Tampon, Menstrual, Unscented Devices (Product Code HEB)
189 devices
Cleared
Mar 20, 2026
Livi Device
Liviwell, Inc.
Obstetrics & Gynecology
266d
Cleared
Dec 17, 2025
Unscented Menstrual Long Applicator Tampon
Unibeauty (Hubei) Technology Co., Ltd.
Obstetrics & Gynecology
23d
Cleared
Oct 09, 2025
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
Cotton High Tech S.L.
Obstetrics & Gynecology
24d
Cleared
Sep 19, 2025
Unscented menstrual three-piece applicator tampon
Unibeauty (Hubei) Technology Co., Ltd.
Obstetrics & Gynecology
31d
Cleared
Aug 13, 2025
Unscented menstrual long applicator tampon
Unibeauty (Hubei) Technology Co., Ltd.
Obstetrics & Gynecology
132d
Cleared
Apr 01, 2025
SABA Tampons
Essity Higiene Y Salud Mexico. S.A. DE C.V.
Obstetrics & Gynecology
257d
Cleared
Jan 10, 2025
Unscented Tampon
Shandong Intco Hygiene Products Co., Ltd.
Obstetrics & Gynecology
267d
Cleared
May 10, 2024
Organic Cotton Tampon
Suzhou Borage Medical Technology Co., Ltd.
Obstetrics & Gynecology
56d
Cleared
Apr 12, 2024
TOSAMA Reusable Applicator
Tosama, D.O.O.
Obstetrics & Gynecology
276d
Cleared
Dec 15, 2023
Unscented Menstrual Tampon
Unibeauty (Hubei) Technology Co., Ltd.
Obstetrics & Gynecology
109d
Cleared
Aug 18, 2023
Daye Tampon
Annes Daye, Ltd.
Obstetrics & Gynecology
234d
Cleared
Aug 14, 2023
Organic cotton tampon, Viscose tampon
Zhejiang Tianqing Manufacturing Technology Group Co., Ltd.
Obstetrics & Gynecology
97d
Cleared
Aug 03, 2023
Sequel Tampon with Plastic Applicator
Tampro, Inc.
Obstetrics & Gynecology
168d
Cleared
Jan 06, 2023
U by Kotex® Click® Unscented Menstrual Tampons
Kimberly Clark Corporation
Obstetrics & Gynecology
23d
Cleared
Sep 30, 2022
Unscented Menstrual Tampon
Suzhou Borage Medical Technology Co., Ltd.
Obstetrics & Gynecology
81d
Cleared
Apr 21, 2022
Tempo Tampon
Dong-A Pharmaceutical Co., Ltd.
Obstetrics & Gynecology
275d
Cleared
Feb 25, 2022
Cohitech Cottonlock Tampons with Reusable Applicator
Cotton High Tech S.L.
Obstetrics & Gynecology
28d
Cleared
Oct 22, 2021
Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
Cotton High Tech S.L.
Obstetrics & Gynecology
135d
Cleared
Oct 08, 2021
Cohitech Reusable Tampon Applicator
Cotton High Tech S.L.
Obstetrics & Gynecology
60d
Cleared
Sep 17, 2021
Tempo Natural Tampon
Dong-A Pharmaceutical Co., Ltd.
Obstetrics & Gynecology
59d
Cleared
Aug 19, 2021
Callaly Tampliner (super plus absorbency)
Calla Lily Personal Care, Ltd.
Obstetrics & Gynecology
27d
Cleared
Aug 13, 2021
Every Cycle Reusable Tampon Applicator
Cycle, LLC
Obstetrics & Gynecology
88d
Cleared
Jun 10, 2021
Callaly Tampliner
Calla Lily Personal Care, Ltd.
Obstetrics & Gynecology
30d
Cleared
Dec 07, 2020
Callaly Tampliner
Calla Lily Personal Care, Ltd.
Obstetrics & Gynecology
235d
About Product Code HEB - Regulatory Context
510(k) Submission Activity
189 total 510(k) submissions under product code HEB since 1978, with 189 receiving FDA clearance (average review time: 114 days).
Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.
FDA 510(k) Review Time - HEB Product Code
Recent submissions under HEB have taken an average of 143 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.
HEB devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →