LEL · Class II · 21 CFR 882.5050

FDA Product Code LEL: Device, Sleep Assessment

Leading manufacturers include Respironics, Inc., Actigraph and Actigraph, LLC.

19
Total
19
Cleared
141d
Avg days
1979
Since
Stable submission activity - 3 submissions in the last 2 years
Review times improving: avg 107d recently vs 147d historically

FDA 510(k) Cleared Device, Sleep Assessment Devices (Product Code LEL)

19 devices
1–19 of 19
Cleared Dec 22, 2025
EmbraceMini
K252981
Empatica S.R.L.
Neurology · 96d
Cleared Jul 31, 2025
Sleep Watch
K251574
Ambulatory Monitoring, Inc.
Neurology · 70d
Cleared Apr 16, 2025
DCM (PW-DCM)
K243513
Pneumowave, Ltd.
Neurology · 155d
Cleared Jun 17, 2024
VERABAND™
K233987
Arbor Medical Innovations, LLC
Neurology · 182d
Cleared Apr 03, 2024
Oxevision Sleep Device
K233618
Oxehealth Limited
Neurology · 142d
Cleared Jun 23, 2023
ActiGraph LEAP activity monitor (ActiGraph LEAP)
K231532
Actigraph, LLC
Neurology · 28d
Cleared May 24, 2018
ActiGraph CentrePoint Insight Watch
K181077
Actigraph
Neurology · 30d
Cleared Feb 09, 2001
REMVIEW SLEEP RECORDER, MODEL 320
K003499
Respironics, Inc.
Neurology · 88d

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 remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - LEL Product Code

Recent submissions under LEL have taken an average of 107 days to reach a decision - down from 147 days historically, suggesting improved FDA processing for this classification.

LEL devices are reviewed by the Neurology panel. Browse all Neurology devices →