Cleared Traditional

Neural Navigator (K191422) - FDA 510(k) Clearance

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

K191422 · Soterix Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
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Apr 2020
Decision
313d
Days
Class 2
Risk

K191422 is an FDA 510(k) clearance for the Neural Navigator. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Soterix Medical, Inc. (New York, US). The FDA issued a Cleared decision on April 6, 2020 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Soterix Medical, Inc. devices

Submission Details

510(k) Number K191422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2019
Decision Date April 06, 2020
Days to Decision 313 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
165d slower than avg
Panel avg: 148d · This submission: 313d
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 156
Devices cleared under the same product code (HAW) and FDA review panel - the closest regulatory comparables to K191422.
Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
K192703 · Brainlab AG · Oct 2020
StealthStation Cranial Software v1.3.0
K201175 · Medtronic Navigation, Inc. · Jun 2020
ROSA ONE Brain application
K200511 · Medtech S.A · May 2020
ClearPoint System and Accessories
K200079 · Mri Interventions, Inc. · Feb 2020
7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
K192945 · 7D Surgical, Inc. · Nov 2019
Stealth Autoguide System, Midas Rex Legend Depth Stop System
K191597 · Medtronic Navigation, Inc. · Nov 2019