Cleared Traditional

K250893 - Ball Joint Guide Array (66295) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250893 · Bayer Medical Care, Inc. · Neurology device
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Sep 2025
Decision
163d
Days
Class 2
Risk

K250893 is an FDA 510(k) clearance for the Ball Joint Guide Array (66295). Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Bayer Medical Care, Inc. (Indianaola, US). The FDA issued a Cleared decision on September 4, 2025 after a review of 163 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 Bayer Medical Care, Inc. devices

Submission Details

510(k) Number K250893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2025
Decision Date September 04, 2025
Days to Decision 163 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
15d slower than avg
Panel avg: 148d · This submission: 163d
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 422
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K250893.
Zeta Navigation System
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NeuroAlign software
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SOLOPASS 2.0 System
K251317 · Intravent Medical Partners · Sep 2025
EZ-FIDUCIALS
K250505 · Phasor Health, LLC · Jul 2025
Stereotaxic Guiding Surgical Devices, NaoTrac S
K242575 · Brain Navi Biotechnology Co., Ltd. · May 2025