Cleared Traditional

K992194 - CORTICAL MAPPING UNIT

K992194 is an FDA 510(k) clearance for CORTICAL MAPPING UNIT, manufactured by Ad-Tech Medical Instrument Corp. The device is a Class 2 Neurology device with product code GYC cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K992194 · Ad-Tech Medical Instrument Corp · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
76d
Days
Class 2
Risk

K992194 is an FDA 510(k) clearance for the CORTICAL MAPPING UNIT, MODEL CMU. Classified as Electrode, Cortical (product code GYC), Class II - Special Controls.

Submitted by Ad-Tech Medical Instrument Corp (Racine, US). The FDA issued a Cleared decision on September 13, 1999 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1310 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ad-Tech Medical Instrument Corp devices

FDA 510(k) Submission Details - K992194

510(k) Number K992194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1999
Decision Date September 13, 1999
Days to Decision 76 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
72d faster than avg
Panel avg: 148d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GYC Device Classification - Class 2, Special Controls

Product Code GYC Electrode, Cortical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1310
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 - GYC Electrode, Cortical

All 20
Devices cleared under the same product code (GYC) and FDA review panel - the closest regulatory comparables to K992194.
PMT SUBDURAL CORTICAL ELECTRODES
K082474 · Pmt Corp. · May 2009
NICOLET CORTICAL STIMULATOR
K072964 · Cardinal Health, Inc. · Dec 2008
DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
K053363 · Ad-Tech Medical Instrument Corp · May 2006
EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
K961942 · Radionics, Inc. · Aug 1997
AD-TECH SUBDURAL ELECTRODE
K970587 · Ad-Tech Medical Instrument Corp · May 1997
STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE
K964224 · Pmt Corp. · Mar 1997