Cleared Traditional

K011964 - INSIGHT MILLENNIUM PLUS

K011964 is an FDA 510(k) clearance for INSIGHT MILLENNIUM PLUS, manufactured by Fasstech. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K011964 · Fasstech · Neurology device
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Sep 2001
Decision
87d
Days
Class 2
Risk

K011964 is an FDA 510(k) clearance for the INSIGHT MILLENNIUM PLUS. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Fasstech (Burlington, US). The FDA issued a Cleared decision on September 20, 2001 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - 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 Fasstech devices

FDA 510(k) Submission Details - K011964

510(k) Number K011964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2001
Decision Date September 20, 2001
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 - HCC Device, Biofeedback

All 43
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K011964.
POLYGRAM NET BIOFEEDBACK APPLICATION
K041244 · Medtronic Vascular · Aug 2004
SONDREX P.A.L. SYSTEM
K010388 · Ohmeda Medical · Dec 2001
EAR MUFFINS
K012384 · Bio-Logic Systems Corp. · Oct 2001
NEUROCOMP
K993654 · Neurocybernetics · Jan 2000
NORODYN 8000 SEMG SYSTEM, ND-8000
K992439 · Myotronics-Noromed, Inc. · Aug 1999
INSIGHT MILLENNIUM
K990778 · Fasstech · Jun 1999