Cleared Traditional

K223288 - Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

K223288 is an FDA 510(k) clearance for Cranial Navigation, 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 269-day FDA review.

K223288 · Brainlab AG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2023
Decision
269d
Days
Class 2
Risk

K223288 is an FDA 510(k) clearance for the Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofa.... Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on July 21, 2023 after a review of 269 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 Brainlab AG devices

FDA 510(k) Submission Details - K223288

510(k) Number K223288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2022
Decision Date July 21, 2023
Days to Decision 269 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
121d slower than avg
Panel avg: 148d · This submission: 269d
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 331
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K223288.
ClearPoint Array System (Version 1.2)
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Zeta Cranial Navigation System
K230661 · Zeta Surgical · Sep 2023
ROSA ONE Brain Application
K231103 · Medtech S.A.S · Jul 2023
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K231392 · Navinetics, Inc. · Jul 2023
Sinobot X1
K220072 · Sinovation (Beijing) Medical Technology Co., Ltd. · Jun 2023