FDA Product Code JAF: Monitor, Ultrasonic, Nonfetal

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 510(k) Review Time - JAF Product Code

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 Radiology panel. Browse all Radiology devices →

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