Cleared Traditional

K001467 - DA VINCHI EMG/EP ISA1004EP

K001467 is an FDA 510(k) clearance for DA VINCHI EMG/EP ISA1004EP, manufactured by Airsep Corp.. The device is a Class 2 Neurology device with product code GWE cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K001467 · Airsep Corp. · Neurology device
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Aug 2000
Decision
83d
Days
Class 2
Risk

K001467 is an FDA 510(k) clearance for the DA VINCHI EMG/EP ISA1004EP. Classified as Stimulator, Photic, Evoked Response (product code GWE), Class II - Special Controls.

Submitted by Airsep Corp. (Buffalo, US). The FDA issued a Cleared decision on August 1, 2000 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1890 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Airsep Corp. devices

FDA 510(k) Submission Details - K001467

510(k) Number K001467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2000
Decision Date August 01, 2000
Days to Decision 83 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 148d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWE Device Classification - Class 2, Special Controls

Product Code GWE Stimulator, Photic, Evoked Response
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1890
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 - GWE Stimulator, Photic, Evoked Response

All 21
Devices cleared under the same product code (GWE) and FDA review panel - the closest regulatory comparables to K001467.
Nurochek System
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K011794 · Excel Tech. , Ltd. · Oct 2001
EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)
K991903 · Excel Tech. , Ltd. · Aug 1999
KILOWIN
K971214 · Cadwell Laboratories, Inc. · Jun 1998
TECA/MEDELEC MISTRAL
K880593 · Teca, Inc. · Apr 1988