FDA Product Code HIS: Condom
Male condoms are among the most widely used contraceptive and STI prevention devices. FDA product code HIS covers condoms cleared as contraceptive devices.
These barrier devices are worn over the penis during sexual intercourse to prevent pregnancy and reduce the transmission of sexually transmitted infections including HIV, gonorrhea, and chlamydia. They are available in latex, polyurethane, and natural membrane formulations.
HIS devices are Class II medical devices, regulated under 21 CFR 884.5300 and reviewed by the FDA Obstetrics & Gynecology panel.
Leading manufacturers include Church & Dwight Co., Inc., Lelo, Inc. and Okamoto USA, Inc..
FDA 510(k) Cleared Condom Devices (Product Code HIS)
About Product Code HIS - Regulatory Context
510(k) Submission Activity
400 total 510(k) submissions under product code HIS since 1977, with 400 receiving FDA clearance (average review time: 163 days).
Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 8 in the prior period.
FDA Review Time
Recent submissions under HIS have taken an average of 117 days to reach a decision - down from 163 days historically, suggesting improved FDA processing for this classification.
HIS devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →