Cleared Traditional

K990778 - INSIGHT MILLENNIUM

K990778 is an FDA 510(k) clearance for INSIGHT MILLENNIUM, manufactured by Fasstech. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K990778 · Fasstech · Neurology device
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Jun 1999
Decision
86d
Days
Class 2
Risk

K990778 is an FDA 510(k) clearance for the INSIGHT MILLENNIUM. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Fasstech (Burlington, US). The FDA issued a Cleared decision on June 3, 1999 after a review of 86 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 - K990778

510(k) Number K990778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1999
Decision Date June 03, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 148d · This submission: 86d
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 42
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K990778.
EAR MUFFINS
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K992439 · Myotronics-Noromed, Inc. · Aug 1999
BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE
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THE BAGNOLI-8 EMG SYSTEM
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XYZ SYSTEM
K983550 · Bio-Monitoring International Corp. · Jan 1999