FDA Product Code GYD: Transducer, Tremor
Leading manufacturers include Gkc Manufacturing Pty, Ltd., Rune Labs, Inc. and H2o Bilisim Yazilim.
13
Total
13
Cleared
166d
Avg days
1979
Since
Stable submission activity - 2 submissions in the last 2 years
Consistent review times:
181d avg (recent)
FDA 510(k) Cleared Transducer, Tremor Devices (Product Code GYD)
13 devices
Cleared
Apr 25, 2025
Neu Platform
Neuhealth Digital , Ltd.
Neurology
94d
Cleared
Mar 17, 2023
NeuroRPM
New Touch Digital, Inc.
Neurology
269d
Cleared
Nov 17, 2022
Parky App
H2o Bilisim Yazilim
Neurology
241d
Cleared
Jun 10, 2022
Rune Labs Tremor Transducer System
Rune Labs, Inc.
Neurology
219d
Cleared
Mar 11, 2022
Personal Kinetigraph (PKG) System Gen 2 Plus
Gkc Manufacturing Pty, Ltd.
Neurology
263d
About Product Code GYD - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code GYD since 1979, with 13 receiving FDA clearance (average review time: 166 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - GYD Product Code
FDA review times for GYD submissions have been consistent, averaging 181 days recently vs 164 days historically.
GYD devices are reviewed by the Neurology panel. Browse all Neurology devices →