Cleared Traditional

K030489 - BRM2 BRAIN MONITOR

K030489 is an FDA 510(k) clearance for BRM2 BRAIN MONITOR, manufactured by Brainz Instruments , Ltd.. The device is a Class 2 Neurology device with product code OLT cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K030489 · Brainz Instruments , Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
77d
Days
Class 2
Risk

K030489 is an FDA 510(k) clearance for the BRM2 BRAIN MONITOR. Classified as Non-normalizing Quantitative Electroencephalograph Software (product code OLT), Class II - Special Controls.

Submitted by Brainz Instruments , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on May 2, 2003 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1400 - 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.

FDA 510(k) Submission Details - K030489

510(k) Number K030489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2003
Decision Date May 02, 2003
Days to Decision 77 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 149d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

OLT Device Classification - Class 2, Special Controls

Product Code OLT Non-normalizing Quantitative Electroencephalograph Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Analyze Electroencephalograph Data Using Conventional Methodology To Output And Display Standard Electroencephalograph Parameters For Interpretation By A Qualified User.
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

Underwriters Laboratories, Inc.
CHARLES MACK

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.

Regulatory Peers - OLT Non-normalizing Quantitative Electroencephalograph Software

All 53
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K030489 · BRM2 BRAIN MONITOR
Download PDF FDA Summary Brainz Instruments , …