FDA Product Code LEL: Device, Sleep Assessment
Leading manufacturers include Ambulatory Monitoring, Inc., Empatica S.R.L. and Actigraph, LLC.
FDA 510(k) Cleared Device, Sleep Assessment Devices (Product Code LEL)
About Product Code LEL - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code LEL since 1979, with 19 receiving FDA clearance (average review time: 141 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for LEL submissions have been consistent, averaging 126 days recently vs 144 days historically.
LEL devices are reviewed by the Neurology panel. Browse all Neurology devices →