GWL · Class II · 21 CFR 882.1835

FDA Product Code GWL: Amplifier, Physiological Signal

Leading manufacturers include Eb Neuro S.P.A., Blackrock Microsystems and Neurotronics, Inc..

Total

Cleared

114d

Avg days

1977

Since

Stable submission activity - 4 submissions in the last 2 years

Consistent review times: 98d avg (recent)

FDA 510(k) Cleared Amplifier, Physiological Signal Devices (Product Code GWL)

53 devices

1–24 of 53

Somnomed Technologies Inc., Doing Business AS Remware

Neurology · 181d

Cleared Sep 04, 2024

BE Plus PRO, Neurotravel LIGHT

Dormotech Medical, Ltd.

Digital NeuroPort Biopotential Signal Processing System

K202174

Blackrock Microsystems

Neurology · 190d

About Product Code GWL - Regulatory Context

510(k) Submission Activity

53 total 510(k) submissions under product code GWL since 1977, with 53 receiving FDA clearance (average review time: 114 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA Review Time

FDA review times for GWL submissions have been consistent, averaging 98 days recently vs 115 days historically.

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