Cleared Traditional

K182542 - The EPAD 2 System

K182542 is an FDA 510(k) clearance for The EPAD 2 System, 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 158-day FDA review.

K182542 · Safeop Surgical, Inc. · Neurology device
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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

FDA 510(k) Submission Details - K182542

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.

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 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 96
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