Cleared Traditional

PEDIGUARD NERVE DETECTOR SYSTEM (K030526) - FDA 510(k) Clearance

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

K030526 · Spine Vision, Inc. · Neurology device
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Dec 2004
Decision
679d
Days
Class 2
Risk

K030526 is an FDA 510(k) clearance for the PEDIGUARD NERVE DETECTOR SYSTEM. Classified as Stimulator, Electrical, Evoked Response (product code GWF), Class II - Special Controls.

Submitted by Spine Vision, Inc. (Atlanta, US). The FDA issued a Cleared decision on December 29, 2004 after a review of 679 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Spine Vision, Inc. devices

Submission Details

510(k) Number K030526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2003
Decision Date December 29, 2004
Days to Decision 679 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
531d slower than avg
Panel avg: 148d · This submission: 679d
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 21
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K030526.
The EPAD 2 System
K182542 · Safeop Surgical, Inc. · Feb 2019
SEN-4100 ELECTRIC STIMULATOR
K071969 · Nihon Kohden America, Inc. · Oct 2008
MEE-1000A NEUROMASTER
K051178 · Nihon Kohden America, Inc. · Aug 2005
NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES
K991899 · Nihon Kohden America, Inc. · Sep 1999
NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM
K950208 · Nihon Kohden America, Inc. · May 1995
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS
K912685 · Nihon Kohden America, Inc. · Feb 1992