Cleared Traditional

K030526 - PEDIGUARD NERVE DETECTOR SYSTEM

K030526 is an FDA 510(k) clearance for PEDIGUARD NERVE DETECTOR SYSTEM, manufactured by Spine Vision, Inc.. The device is a Class 2 Neurology device with product code GWF cleared through the Traditional 510(k) pathway after a 679-day FDA review.

K030526 · Spine Vision, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K030526

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.

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 88
Devices cleared under the same product code (GWF) and FDA review panel - the closest regulatory comparables to K030526.
MAGPRO, MODEL R30
K061645 · Tonica Elektronik A/S · Oct 2006
MEE-1000A NEUROMASTER
K051178 · Nihon Kohden America, Inc. · Aug 2005
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
K051384 · Nuvasive, Inc. · Jul 2005
TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR
K042350 · Cadwell Laboratories, Inc. · Nov 2004
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248
K040358 · Excel Tech. , Ltd. · Aug 2004
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
K010092 · Excel Tech. , Ltd. · Apr 2001