Cleared Traditional

Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”) (K253055) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K253055 · Nordic Kinetics AB · Neurology device
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Optimized for regulatory review, auditing and printing
Jun 2026
Decision
268d
Days
Class 2
Risk

K253055 is an FDA 510(k) clearance for the Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”). Classified as Transducer, Tremor (product code GYD), Class II - Special Controls.

Submitted by Nordic Kinetics AB (Lund, SE). The FDA issued a Cleared decision on June 17, 2026 after a review of 268 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1950 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nordic Kinetics AB devices

Submission Details

510(k) Number K253055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2025
Decision Date June 17, 2026
Days to Decision 268 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 148d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYD Transducer, Tremor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1950
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GYD Transducer, Tremor

Devices cleared under the same product code (GYD) and FDA review panel - the closest regulatory comparables to K253055.
Neu Platform
K250153 · Neuhealth Digital , Ltd. · Apr 2025
NeuroRPM
K221772 · New Touch Digital, Inc. · Mar 2023
Parky App
K220820 · H2o Bilisim Yazilim · Nov 2022
Rune Labs Tremor Transducer System
K213519 · Rune Labs, Inc. · Jun 2022
Personal Kinetigraph (PKG) System Gen 2 Plus
K211887 · Gkc Manufacturing Pty, Ltd. · Mar 2022