Cleared Traditional

K103192 - NAVIGATION MARKER, REFLECTIVE MARKER SPHERES

K103192 is an FDA 510(k) clearance for NAVIGATION MARKER, manufactured by Ilumark GmbH. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K103192 · Ilumark GmbH · Neurology device
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Feb 2011
Decision
101d
Days
Class 2
Risk

K103192 is an FDA 510(k) clearance for the NAVIGATION MARKER, REFLECTIVE MARKER SPHERES. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Ilumark GmbH (Muhlheim, DE). The FDA issued a Cleared decision on February 7, 2011 after a review of 101 days - within the typical 510(k) review window.

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 Ilumark GmbH devices

FDA 510(k) Submission Details - K103192

510(k) Number K103192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2010
Decision Date February 07, 2011
Days to Decision 101 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
47d faster than avg
Panel avg: 148d · This submission: 101d
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 278
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K103192.
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