FDA Product Code HFN: Transducer, Pressure, Intrauterine
Leading manufacturers include Clinical Innovations, LLC.
FDA 510(k) Cleared Transducer, Pressure, Intrauterine Devices (Product Code HFN)
About Product Code HFN - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code HFN since 1989, with 9 receiving FDA clearance (average review time: 151 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 HFN have taken an average of 58 days to reach a decision - down from 163 days historically, suggesting improved FDA processing for this classification.
HFN devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →