HEBClass II

Tampon, Menstrual, Unscented

21 CFR 884.5470 / Obstetrics/Gynecology

HEB is the FDA product code for Tampon, Menstrual, Unscented, a class II device type, regulated under 21 CFR 884.5470. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold 189 510(k) clearances under this code, the most recent dated 2026-03-20, and 36 recalls.

Classification record

Product code: HEB
Device name: Tampon, Menstrual, Unscented
FDA 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.
Regulation: 21 CFR 884.5470
Device class: Class II
Review panel: Obstetrics/Gynecology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 189
Ingested recalls: 36

Clearances, product code HEB

By decision year

189 clearances under product code HEB with a decision year between 1978 and 2026, 1987 the highest year at 15.

Show the numbers

510(k) clearances under FDA product code HEB by decision year
Year	Clearances
1978	2
1979	2
1980	2
1981	6
1982	2
1984	4
1985	7
1986	9
1987	15
1988	2
1989	9
1990	2
1991	2
1992	1
1993	5
1994	6
1995	7
1996	8
1997	6
1998	6
1999	2
2000	4
2002	3
2003	2
2004	2
2005	2
2006	3
2008	1
2009	7
2010	3
2011	3
2012	3
2013	2
2014	4
2015	5
2016	1
2017	2
2018	5
2019	7
2020	2
2021	6
2022	3
2023	5
2024	2
2025	6
2026	1

Applicants with the most clearances

Product code HEB

Applicants holding the most 510(k) clearances under product code HEB
Applicant	Clearances
Tambrands Inc.	34
Kimberly-Clark Corporation	16
Personal Products Co.	14
Procter & Gamble Co.	10
First Quality Hygienic, Inc.	8
Cotton High Tech S.L.	7
Playtex, Inc.	7
Rostam, Ltd.	7
Ontex Bvba	5
Tampax, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 86 companies shown, in name order