Cleared Traditional

K223288 - Cranial Navigation

K223288 is the FDA 510(k) clearance for Cranial Navigation by Brainlab AG. It is a Class 2 Neurology device (product code HAW) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K223288 · Brainlab AG · Neurology device
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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

Submission Details

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.

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 217
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K223288.
ClearPoint Array System (Version 1.2)
K232102 · ClearPoint Neuro, Inc. · Sep 2023
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
K223864 · Brainlab AG · Sep 2023
Zeta Cranial Navigation System
K230661 · Zeta Surgical · Sep 2023
ROSA ONE Brain Application
K231103 · Medtech S.A.S · Jul 2023
NaviNetics Reusable Stereotactic System (NN1000)
K231392 · Navinetics, Inc. · Jul 2023
Sinobot X1
K220072 · Sinovation (Beijing) Medical Technology Co., Ltd. · Jun 2023