Cleared Traditional

K220820 - Parky App

K220820 is an FDA 510(k) clearance for Parky App, manufactured by H2o Bilisim Yazilim. The device is a Class 2 Neurology device with product code GYD cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K220820 · H2o Bilisim Yazilim · Neurology device
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Nov 2022
Decision
241d
Days
Class 2
Risk

K220820 is an FDA 510(k) clearance for the Parky App. Classified as Transducer, Tremor (product code GYD), Class II - Special Controls.

Submitted by H2o Bilisim Yazilim (Cankaya, TR). The FDA issued a Cleared decision on November 17, 2022 after a review of 241 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 H2o Bilisim Yazilim devices

FDA 510(k) Submission Details - K220820

510(k) Number K220820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2022
Decision Date November 17, 2022
Days to Decision 241 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 148d · This submission: 241d
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.