HISClass II

Condom

21 CFR 884.5300 / Obstetrics/Gynecology

HIS is the FDA product code for Condom, a class II device type, regulated under 21 CFR 884.5300. As of 2026-09-10, FDA records hold 401 510(k) clearances under this code, the most recent dated 2026-05-04, and 7 recalls.

Classification record

Product code: HIS
Device name: Condom
Regulation: 21 CFR 884.5300
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: 402
Ingested recalls: 7

Clearances, product code HIS

By decision year

402 clearances under product code HIS with a decision year between 1977 and 2026, 1990 the highest year at 43.

Show the numbers

510(k) clearances under FDA product code HIS by decision year
Year	Clearances
1977	2
1979	1
1980	2
1982	4
1983	4
1984	5
1985	4
1986	10
1987	20
1988	25
1989	21
1990	43
1991	12
1992	3
1993	1
1994	7
1995	18
1996	9
1997	16
1998	11
1999	14
2000	30
2001	14
2002	15
2003	10
2004	6
2005	7
2006	8
2007	7
2008	3
2009	5
2010	1
2011	3
2012	7
2013	4
2014	7
2015	3
2016	5
2017	4
2018	2
2019	1
2020	4
2021	5
2022	10
2023	2
2025	5
2026	2

Applicants with the most clearances

Product code HIS

Applicants holding the most 510(k) clearances under product code HIS
Applicant	Clearances
Carter Products	15
Mayer Laboratories	14
Okamoto U.S.A., Inc.	14
Ansell, Inc.	12
Church & Dwight Co., Inc.	12
Remed Pharma	9
Schmid Laboratories, Inc.	9
Innolatex Sdn. Bhd	8
Pleasure Latex Products Sdn. Bhd.	8
Suretex, Ltd.	8

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 74 companies shown, in name order