Cleared Traditional

K190163 - ALARA Neuro Access Kit

K190163 is the FDA 510(k) clearance for ALARA Neuro Access Kit by SurGenTec, LLC. It is a Class 2 Neurology device (product code PDQ) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K190163 · SurGenTec, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
166d
Days
Class 2
Risk

K190163 is an FDA 510(k) clearance for the ALARA Neuro Access Kit. Classified as Neurosurgical Nerve Locator (product code PDQ), Class II - Special Controls.

Submitted by SurGenTec, LLC (Boca Raton, US). The FDA issued a Cleared decision on July 16, 2019 after a review of 166 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 874.1820 - 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 SurGenTec, LLC devices

Submission Details

510(k) Number K190163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2019
Decision Date July 16, 2019
Days to Decision 166 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
18d slower than avg
Panel avg: 148d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDQ Neurosurgical Nerve Locator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
Definition To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.
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

Quality Solutions and Support, LLC
Stephen Inglese

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.

Regulatory Peers - PDQ Neurosurgical Nerve Locator

All 22
Devices cleared under the same product code (PDQ) and FDA review panel - the closest regulatory comparables to K190163.
Neurosign V4 Intraoperative Nerve Monitor
K203684 · Magstim Company, Ltd. · Mar 2021
DSG Connect Technology
K201454 · Spineguard S.A. · Feb 2021
ATEC IOM Accessory Instruments
K191723 · Alphatec Spine, Inc. · Oct 2019
ATEC IOM Accessory Instruments
K182617 · Alphatec Spine, Inc. · May 2019
NAV PAK Needle, NIM NAV PAK Needle
K182662 · Boston Endo Surgical Tech, · Apr 2019
Neurosign V4 Intraoperative Nerve Monitor
K181559 · Magstim Company, Ltd. · Nov 2018