Cleared Traditional

K023147 - ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4

K023147 is an FDA 510(k) clearance for ANALOG MULTIPLEXED CABLE TELEMETRY (AMT..., manufactured by Bortec Biomedical, Ltd.. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K023147 · Bortec Biomedical, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
83d
Days
Class 2
Risk

K023147 is an FDA 510(k) clearance for the ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-.... Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Bortec Biomedical, Ltd. (Seattle, US). The FDA issued a Cleared decision on December 12, 2002 after a review of 83 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.

FDA 510(k) Submission Details - K023147

510(k) Number K023147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2002
Decision Date December 12, 2002
Days to Decision 83 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
66d faster than avg
Panel avg: 149d · This submission: 83d
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 74
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K023147 · ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4
Download PDF FDA Summary Bortec Biomedical, Lt…