FDA Product Code HDB: Extractor, Vacuum, Fetal
Leading manufacturers include Clinical Innovations, LLC.
FDA 510(k) Cleared Extractor, Vacuum, Fetal Devices (Product Code HDB)
About Product Code HDB - Regulatory Context
510(k) Submission Activity
30 total 510(k) submissions under product code HDB since 1977, with 30 receiving FDA clearance (average review time: 141 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 HDB have taken an average of 250 days to reach a decision - up from 137 days historically. Manufacturers should account for longer review timelines in current project planning.
HDB devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →