Cleared Traditional

K132616 - EPAD

K132616 is the FDA 510(k) clearance for EPAD by Safeop Surgical, Inc.. It is a Class 2 Neurology device (product code GWF) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K132616 · Safeop Surgical, Inc. · Neurology device
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Jan 2014
Decision
156d
Days
Class 2
Risk

K132616 is an FDA 510(k) clearance for the EPAD. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Safeop Surgical, Inc. (Amherst, US). The FDA issued a Cleared decision on January 24, 2014 after a review of 156 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1870 - 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 Safeop Surgical, Inc. devices

Submission Details

510(k) Number K132616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2013
Decision Date January 24, 2014
Days to Decision 156 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
8d slower than avg
Panel avg: 148d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWF Stimulator, Electrical, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1870
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 - GWF Stimulator, Electrical, Evoked Response

All 51
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K132616.
Neuro-IOM system with Neuro-IOM.NET software
K190703 · Neurosoft , Ltd. · May 2021
NIM Vital, Nerve Integrity Monitor
K200759 · Medtronic Xomed, Inc. · Oct 2020
The EPAD 2 System
K182542 · Safeop Surgical, Inc. · Feb 2019
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
K094054 · Nuvasive, Inc. · May 2010
NUVASIVE NEURO VISION SYSTEM
K090298 · Nuvasive, Inc. · Jun 2009
NIM 3.0
K083124 · Medtronic Xomed, Inc. · Feb 2009