Cleared Traditional

K991077 - MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)

K991077 is an FDA 510(k) clearance for MICROELECTROENCEPHALOGRAPHY PROFESSIONA..., manufactured by Microrecording Systems Consultants, LLC. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K991077 · Microrecording Systems Consultants, LLC · Neurology device
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Jun 1999
Decision
70d
Days
Class 2
Risk

K991077 is an FDA 510(k) clearance for the MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000). Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Microrecording Systems Consultants, LLC (Pasadena, US). The FDA issued a Cleared decision on June 9, 1999 after a review of 70 days - a notably fast clearance 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: 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 Microrecording Systems Consultants, LLC devices

FDA 510(k) Submission Details - K991077

510(k) Number K991077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1999
Decision Date June 09, 1999
Days to Decision 70 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 148d · This submission: 70d
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 34
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K991077.
MICROTARGETING ELECTRODE
K991522 · FHC, Inc. · Aug 2000
NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
K993622 · Alpha Omega , Ltd. · Jan 2000
AD-TECH'S FORAMEN OVALE ELECTRODE
K990788 · Ad-Tech Medical Instrument Corp · Nov 1999
NEUROMAP
K981820 · Radionics, Inc. · Nov 1998
PALI-TRODE
K981015 · Preferred Instruments · Jun 1998
AD-TECH'S SPINAL ELECTRODE
K973454 · Ad-Tech Medical Instrument Corp · Jun 1998