Cleared Traditional

K132616 - EPAD

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

K132616 · Safeop Surgical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K132616

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
Combination Product No
PCCP Authorized No
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.

GWF Device Classification - Class 2, Special Controls

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 95
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K132616.
MagPro R20
K160280 · Tonica Elektronik A/S · May 2016
STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
K150220 · Eb Neuro S.P.A. · Aug 2015
Neuromaster G1 MEE200
K142624 · Nihon Kohden Corporation · Apr 2015
MAGSTIM DOUBLE 70-2 COIL
K130403 · The Magstim Company , Ltd. · Aug 2013
NEUROEPG SYSTEM
K123843 · Strohl Medical Technologies · Jun 2013
SYNERGY FOCUS DESKTOP VERSION
K130346 · Natus Neurology Incorporated · May 2013