Cleared Traditional

The EPAD 2 System (K182542) - FDA 510(k) Clearance

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

K182542 · Safeop Surgical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
158d
Days
Class 2
Risk

K182542 is an FDA 510(k) clearance for the The EPAD 2 System. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Safeop Surgical, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on February 22, 2019 after a review of 158 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 K182542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2018
Decision Date February 22, 2019
Days to Decision 158 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
10d slower than avg
Panel avg: 148d · This submission: 158d
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 Consultant

Alphatec Spine, Inc.
Jeremy Markovich

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 - GWF Stimulator, Electrical, Evoked Response

All 138
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K182542.
SafeOp 3: Neural Informatix System
K252842 · Alphatec Spine, Inc. · Jan 2026
Nicolet EDX
K243982 · Natus Neurology Incorporated · Jan 2025
Natus Ultrapro S100 (982A0594)
K243495 · Natus Neurology Incorporated · Dec 2024
Delphi Stimulator
K242345 · Quantalx Neuroscience · Nov 2024
SafeOp 3: Neural Informatix Systeem
K234092 · Alphatec Spine, Inc. · Apr 2024
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
K234080 · Soterix Medical, Inc. · Mar 2024