Cleared Traditional

K142024 - BRIGHTMATTER NAVIGATION SYSTEM

K142024 is an FDA 510(k) clearance for BRIGHTMATTER NAVIGATION SYSTEM, manufactured by Synaptive Medical, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K142024 · Synaptive Medical, Inc. · Neurology device
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Apr 2015
Decision
251d
Days
Class 2
Risk

K142024 is an FDA 510(k) clearance for the BRIGHTMATTER NAVIGATION SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Synaptive Medical, Inc. (Toronto, CA). The FDA issued a Cleared decision on April 2, 2015 after a review of 251 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - 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.

View all Synaptive Medical, Inc. devices

FDA 510(k) Submission Details - K142024

510(k) Number K142024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2014
Decision Date April 02, 2015
Days to Decision 251 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 148d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 - HAW Neurological Stereotaxic Instrument

All 243
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K142024.
StealthStation System with Cranial Software
K153660 · Medtronic Navigation, Inc. · Sep 2016
Leksell Stereotactic System, Injection/ Aspiration Needle Kit
K152558 · Elekta Instrument AB · Mar 2016
Synergy Cranial
K150216 · Medtronic Navigation, Inc. · Jun 2015
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
K141833 · Medtronic Navigation, Inc. · Mar 2015
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
K133444 · Medtronic Navigation, Inc. · Jul 2014
STRYKER KWIC NEEDLE
K140868 · Orthovita, Inc. · Jun 2014