Cleared Traditional

ClearPoint System (K181195) - FDA 510(k) Clearance

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

K181195 · Mri Interventions, Inc. · Neurology device
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Nov 2018
Decision
182d
Days
Class 2
Risk

K181195 is an FDA 510(k) clearance for the ClearPoint System. Classified as Neurological Stereotaxic Instrument, Real-time Intraoperative Mri (product code ORR), Class II - Special Controls.

Submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on November 2, 2018 after a review of 182 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 Mri Interventions, Inc. devices

Submission Details

510(k) Number K181195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2018
Decision Date November 02, 2018
Days to Decision 182 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
34d slower than avg
Panel avg: 148d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ORR Neurological Stereotaxic Instrument, Real-time Intraoperative Mri
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition To Aid The Surgeon In Planning And Conducting General Stereotactic Neurosurgery In An Mri Suite.
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 J. 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.