FDA Product Code HGM: System, Monitoring, Perinatal
Continuous fetal monitoring enables early detection of fetal compromise during labor. FDA product code HGM covers perinatal monitoring systems.
These systems simultaneously record fetal heart rate and uterine contractions via external Doppler and tocodynamometer transducers, providing a continuous cardiotocograph for the assessment of fetal wellbeing and labor progress.
HGM devices are Class II medical devices, regulated under 21 CFR 884.2740 and reviewed by the FDA Obstetrics & Gynecology panel.
Leading manufacturers include Huntleigh Healthcare , Ltd., Sibel Health, Inc. and Ge Medical Systems Information Technologies, Inc..
FDA 510(k) Cleared System, Monitoring, Perinatal Devices (Product Code HGM)
About Product Code HGM - Regulatory Context
510(k) Submission Activity
214 total 510(k) submissions under product code HGM since 1976, with 214 receiving FDA clearance (average review time: 145 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under HGM have taken an average of 262 days to reach a decision - up from 142 days historically. Manufacturers should account for longer review timelines in current project planning.
HGM devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →