Cleared Traditional

K253055 - Sine Monitoring Parkinson’s Disease Tre...

K253055 is an FDA 510(k) clearance for Sine Monitoring Parkinson’s Disease Tre..., manufactured by Nordic Kinetics AB. The device is a Class 2 Neurology device with product code GYD cleared through the Traditional 510(k) pathway after a 268-day FDA review.

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

FDA 510(k) Submission Details - K253055

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.

GYD Device Classification - Class 2, Special Controls

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