FDA Product Code POM: Computerized Cognitive Assessment Aid For Concussion
For Use As An Assessment Aid In The Management Of Concussion.
Leading manufacturers include Vista Lifesciences, Inc., Impact Applications, Inc. and Sway Medical, Inc..
FDA 510(k) Cleared Computerized Cognitive Assessment Aid For Concussion Devices (Product Code POM)
About Product Code POM - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code POM since 2016, with 7 receiving FDA clearance (average review time: 181 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under POM have taken an average of 243 days to reach a decision - up from 172 days historically. Manufacturers should account for longer review timelines in current project planning.
POM devices are reviewed by the Neurology panel. Browse all Neurology devices →