FDA Product Code HHE: Cup, Menstrual
A Menstrual Cup Is A Receptacle Placed In The Vagina To Collect Menstrual Flow.
Leading manufacturers include Menstrual Mates.
FDA 510(k) Cleared Cup, Menstrual Devices (Product Code HHE)
About Product Code HHE - Regulatory Context
510(k) Submission Activity
16 total 510(k) submissions under product code HHE since 1981, with 16 receiving FDA clearance (average review time: 216 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under HHE have taken an average of 266 days to reach a decision - up from 213 days historically. Manufacturers should account for longer review timelines in current project planning.
HHE devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →