FDA Product Code JAF: Monitor, Ultrasonic, Nonfetal
Leading manufacturers include Laminar Digital Health, Inc..
FDA 510(k) Cleared Monitor, Ultrasonic, Nonfetal Devices (Product Code JAF)
About Product Code JAF - Regulatory Context
510(k) Submission Activity
38 total 510(k) submissions under product code JAF since 1978, with 38 receiving FDA clearance (average review time: 140 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 JAF have taken an average of 114 days to reach a decision - down from 141 days historically, suggesting improved FDA processing for this classification.
JAF devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →