Cleared Traditional

K214040 - ClearPoint Array System (version 1.1)

K214040 is an FDA 510(k) clearance for ClearPoint Array System (version 1.1), manufactured by ClearPoint Neuro, Inc.. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K214040 · ClearPoint Neuro, Inc. · Neurology device
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Apr 2022
Decision
110d
Days
Class 2
Risk

K214040 is an FDA 510(k) clearance for the ClearPoint Array System (version 1.1). 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 April 12, 2022 after a review of 110 days - within the typical 510(k) review window.

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 ClearPoint Neuro, Inc. devices

FDA 510(k) Submission Details - K214040

510(k) Number K214040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2021
Decision Date April 12, 2022
Days to Decision 110 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
38d faster than avg
Panel avg: 148d · This submission: 110d
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 Consultant

Hogan Lovells US LLP
John Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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All 242
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