Cleared Traditional

K100038 - DISPOSABLE REFLECTIVE MARKER SPHERES

K100038 is an FDA 510(k) clearance for DISPOSABLE REFLECTIVE MARKER SPHERES, manufactured by Brainlab AG. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K100038 · Brainlab AG · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
188d
Days
Class 2
Risk

K100038 is an FDA 510(k) clearance for the DISPOSABLE REFLECTIVE MARKER SPHERES. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Feldkirchen, DE). The FDA issued a Cleared decision on July 14, 2010 after a review of 188 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.

FDA 510(k) Submission Details - K100038

510(k) Number K100038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2010
Decision Date July 14, 2010
Days to Decision 188 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 149d · This submission: 188d
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 426
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K100038.
NAVIGATION MARKER, REFLECTIVE MARKER SPHERES
K103192 · Ilumark GmbH · Feb 2011
ROSA SURGICAL DEVICE
K101791 · Medtech S.A.S · Sep 2010
TENZING SYSTEM
K102130 · Mazor Surgical Technologies , Ltd. · Aug 2010
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
K092467 · Brainlab AG · May 2010
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
K100314 · Medacta International S.A. · Mar 2010
WAYPOINT STEREOTACTIC SYSTEM
K092192 · FHC, Inc. · Feb 2010
K100038 · DISPOSABLE REFLECTIVE MARKER SPHERES
Download PDF FDA Summary Brainlab AG