FDA Product Code KNG: Monitor, Ultrasonic, Fetal
Leading manufacturers include Contec Medical Systems Co.,Ltd, Shenzhen Jamr Technology Co., Ltd. and Shenzhen Bestman Instrument Co., Ltd..
FDA 510(k) Cleared Monitor, Ultrasonic, Fetal Devices (Product Code KNG)
About Product Code KNG - Regulatory Context
510(k) Submission Activity
60 total 510(k) submissions under product code KNG since 1976, with 60 receiving FDA clearance (average review time: 146 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under KNG have taken an average of 224 days to reach a decision - up from 140 days historically. Manufacturers should account for longer review timelines in current project planning.
KNG devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →