Cleared Traditional

K042384 - NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM

K042384 is an FDA 510(k) clearance for NEUROPORT RECORDING MICROELECTRODE ARRA..., manufactured by Cyberkinetics, Inc. (Cki). The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K042384 · Cyberkinetics, Inc. (Cki) · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
209d
Days
Class 2
Risk

K042384 is an FDA 510(k) clearance for the NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM. Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Cyberkinetics, Inc. (Cki) (Salt Lake City, US). The FDA issued a Cleared decision on March 29, 2005 after a review of 209 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - 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.

FDA 510(k) Submission Details - K042384

510(k) Number K042384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2004
Decision Date March 29, 2005
Days to Decision 209 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
60d slower than avg
Panel avg: 149d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZL Device Classification - Class 2, Special Controls

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
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 - GZL Electrode, Depth

All 57
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K042384.
DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
K053358 · Ad-Tech Medical Instrument Corp · May 2006
NEUROPROBES
K052527 · Alpha Omega Engineering , Ltd. · Apr 2006
NEURODRIVE SYSTEM
K051830 · Alpha Omega , Ltd. · Sep 2005
ISIS MER SYSTEM/ELEKTA MER SYSTEM
K042208 · Inomed Medizintechnik GmbH · Mar 2005
MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
K041409 · Inomed GmbH · Aug 2004
MACRO-MICRO DEPTH ELECTRODE
K041604 · Ad-Tech Medical Instrument Corp · Aug 2004
K042384 · NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
Download PDF FDA Summary Cyberkinetics, Inc. (…