Cleared Special

ClearPoint Array System (Version 1.2) (K232102) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K232102 · ClearPoint Neuro, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
63d
Days
Class 2
Risk

K232102 is an FDA 510(k) clearance for the ClearPoint Array System (Version 1.2). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by ClearPoint Neuro, Inc. (Irvine, US). The FDA issued a Cleared decision on September 15, 2023 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all ClearPoint Neuro, Inc. devices

Submission Details

510(k) Number K232102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2023
Decision Date September 15, 2023
Days to Decision 63 days
Submission Type Special
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
85d faster than avg
Panel avg: 148d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 156
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K232102.
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K223864 · Brainlab AG · Sep 2023
Zeta Cranial Navigation System
K230661 · Zeta Surgical · Sep 2023
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
K223288 · Brainlab AG · Jul 2023