Cleared Traditional

K211887 - Personal Kinetigraph (PKG) System Gen 2...

K211887 is an FDA 510(k) clearance for Personal Kinetigraph (PKG) System Gen 2..., manufactured by Gkc Manufacturing Pty, Ltd.. The device is a Class 2 Neurology device with product code GYD cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K211887 · Gkc Manufacturing Pty, Ltd. · Neurology device
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Mar 2022
Decision
263d
Days
Class 2
Risk

K211887 is an FDA 510(k) clearance for the Personal Kinetigraph (PKG) System Gen 2 Plus. Classified as Transducer, Tremor (product code GYD), Class II - Special Controls.

Submitted by Gkc Manufacturing Pty, Ltd. (Melbourne, AU). The FDA issued a Cleared decision on March 11, 2022 after a review of 263 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 Gkc Manufacturing Pty, Ltd. devices

FDA 510(k) Submission Details - K211887

510(k) Number K211887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2021
Decision Date March 11, 2022
Days to Decision 263 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
115d slower than avg
Panel avg: 148d · This submission: 263d
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 Consultant

DuVal & Associates, P.A.
Kathy Herzog

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.