GYD · Class II · 21 CFR 882.1950

FDA Product Code GYD: Transducer, Tremor

Leading manufacturers include Gkc Manufacturing Pty, Ltd., Kneu Health Digital , Ltd. and Axon Instruments, Inc..

15
Total
15
Cleared
159d
Avg days
1979
Since
Growing category - 4 submissions in the last 2 years vs 2 in the prior period
Consistent review times: 146d avg (recent)

FDA 510(k) Cleared Transducer, Tremor Devices (Product Code GYD)

15 devices
1–15 of 15
Cleared Aug 20, 2026
Kneu Platform (V2)
K262515
Kneu Health Digital , Ltd.
Neurology · 30d
Cleared Aug 14, 2026
Empatica Health Monitoring Platform for Parkinson's Disease Monitoring
K260374
Empatica S.R.L.
Neurology · 190d
Cleared Jun 17, 2026
Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)
K253055
Nordic Kinetics AB
Neurology · 268d
Cleared Apr 25, 2025
Neu Platform
K250153
Neuhealth Digital , Ltd.
Neurology · 94d
Cleared Mar 17, 2023
NeuroRPM
K221772
New Touch Digital, Inc.
Neurology · 269d
Cleared Nov 17, 2022
Parky App
K220820
H2o Bilisim Yazilim
Neurology · 241d
Cleared Jun 10, 2022
Rune Labs Tremor Transducer System
K213519
Rune Labs, Inc.
Neurology · 219d
Cleared Mar 11, 2022
Personal Kinetigraph (PKG) System Gen 2 Plus
K211887
Gkc Manufacturing Pty, Ltd.
Neurology · 263d
Cleared Sep 20, 2016
Personal Kinetigraph (PKG) System
K161717
Gkc Manufacturing Pty, Ltd.
Neurology · 90d
Cleared Aug 22, 2014
PERSONAL KINETIGRAPH (PKG) SYSTEM
K140086
Gkc Manufacturing Pty, Ltd.
Neurology · 220d
Cleared Apr 06, 2007
KINESIA
K063872
Cleveland Medical Devices, Inc.
Neurology · 98d
Cleared Jul 25, 2001
TREMOROMETER
K010270
Flexable Systems, Inc.
Neurology · 177d
Cleared Jul 13, 2001
MODEL 100 ACTIVITY MONITOR
K011429
Telecom Medical, Inc.
Neurology · 65d
Cleared Jul 28, 1997
MM-1 MOVEMENT MONITOR
K971318
Axon Instruments, Inc.
Neurology · 110d

About Product Code GYD - Regulatory Context

510(k) Submission Activity

15 total 510(k) submissions under product code GYD since 1979, with 15 receiving FDA clearance (average review time: 159 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 510(k) Review Time - GYD Product Code

FDA review times for GYD submissions have been consistent, averaging 146 days recently vs 164 days historically.

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