Cleared Traditional

K142438 - Nerve Monitoring Cable System (FDA 510(k) Clearance)

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

K142438 · Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) · Neurology device
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Mar 2015
Decision
188d
Days
Class 2
Risk

K142438 is an FDA 510(k) clearance for the Nerve Monitoring Cable System. Classified as Neurosurgical Nerve Locator (product code PDQ), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on March 5, 2015 after a review of 188 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 Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) devices

Submission Details

510(k) Number K142438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2014
Decision Date March 05, 2015
Days to Decision 188 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 148d · This submission: 188d
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 Peers - PDQ Neurosurgical Nerve Locator

All 34
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