Cleared Traditional

K071449 - BRM3 BRAIN MONITOR

K071449 is an FDA 510(k) clearance for BRM3 BRAIN MONITOR, manufactured by Brainz Instruments , Ltd.. The device is a Class 2 Neurology device with product code OMA cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K071449 · Brainz Instruments , Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
113d
Days
Class 2
Risk

K071449 is an FDA 510(k) clearance for the BRM3 BRAIN MONITOR. Classified as Amplitude-integrated Electroencephalograph (product code OMA), Class II - Special Controls.

Submitted by Brainz Instruments , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on September 14, 2007 after a review of 113 days - within the typical 510(k) review window.

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: 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 - K071449

510(k) Number K071449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2007
Decision Date September 14, 2007
Days to Decision 113 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
36d faster than avg
Panel avg: 149d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

OMA Device Classification - Class 2, Special Controls

Product Code OMA Amplitude-integrated Electroencephalograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1400
Definition Measure And Record Electrical Activity Of The Brain By Acquisition Of Amplitude-integrated Electroencephalograph (electroencephalograph Signals That Have Been Filtered And Displayed In A Specific Manner).
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.
MORTEN SIMON CHRISTENSEN

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 - OMA Amplitude-integrated Electroencephalograph

All 15
Devices cleared under the same product code (OMA) and FDA review panel - the closest regulatory comparables to K071449.
OLYMPIC BRAINZ MONITOR MODEL OBM70001
K093949 · Natus Medical, Inc. · Jun 2010
TWIN NEUROTRAC-III
K081551 · Astro-Med, Inc. · Dec 2008
COMPONENT NEUROMONITORING SYSTEM
K080217 · Moberg Research, Inc. · Nov 2008
OLYMPIC CFM 6000
K031149 · Olympic Medical Corp. · May 2003
OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM
K983229 · Olympic Medical Corp. · Mar 1999
CEREBRAL FUNCTION MONITOR 870
K791580 · Applied Medical Research · Sep 1979
K071449 · BRM3 BRAIN MONITOR
Download PDF FDA Summary Brainz Instruments , …