Cleared Traditional

K864641 - VENTEX-IA

K864641 is an FDA 510(k) clearance for VENTEX-IA, manufactured by Ventech Corp.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K864641 · Ventech Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
63d
Days
Class 2
Risk

K864641 is an FDA 510(k) clearance for the VENTEX-IA. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Ventech Corp. (Philadelphia, US). The FDA issued a Cleared decision on January 28, 1987 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.1375 - 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 Ventech Corp. devices

FDA 510(k) Submission Details - K864641

510(k) Number K864641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1986
Decision Date January 28, 1987
Days to Decision 63 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 148d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 43
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K864641.
PHASIS ELECTROMYOGRAPH
K922488 · Biosound, Inc. · Mar 1993
EMG NAVIGATOR & EMG TRAVELER
K893130 · Bio-Logic Systems Corp. · Mar 1990
MODIFIED NICOLET VIKING SYSTEM
K880573 · Nicolet Biomedical Instruments · Mar 1988
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630 · Chattanooga Group, Inc. · Dec 1986
NICOLET VIKING
K842956 · Nicolet Biomedical Instruments · Aug 1984
CA2000
K842611 · Nicolet Biomedical Instruments · Jul 1984