FDA Product Code HDX: Dilator, Vaginal
Leading manufacturers include Lujena, Inc. and Plus EV Holdings Dba Intimate Rose.
FDA 510(k) Cleared Dilator, Vaginal Devices (Product Code HDX)
About Product Code HDX - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code HDX since 2001, with 9 receiving FDA clearance (average review time: 219 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under HDX have taken an average of 57 days to reach a decision - down from 239 days historically, suggesting improved FDA processing for this classification.
HDX devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →