Cleared Traditional

K023209 - INSIGHT MILLENNIUM III

K023209 is an FDA 510(k) clearance for INSIGHT MILLENNIUM III, manufactured by Fasstech. The device is a Class 2 Neurology device with product code IKN cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K023209 · Fasstech · Neurology device
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Oct 2003
Decision
379d
Days
Class 2
Risk

K023209 is an FDA 510(k) clearance for the INSIGHT MILLENNIUM III. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Fasstech (North Billerica, US). The FDA issued a Cleared decision on October 10, 2003 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fasstech devices

FDA 510(k) Submission Details - K023209

510(k) Number K023209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2002
Decision Date October 10, 2003
Days to Decision 379 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
231d slower than avg
Panel avg: 148d · This submission: 379d
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 31
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