Cleared Traditional

BIOINTEGRATOR, BIOINTEGRATOR PLUS (K942769) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K942769 · Bio Research Institute · Neurology device
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Sep 1995
Decision
445d
Days
Class 2
Risk

K942769 is an FDA 510(k) clearance for the BIOINTEGRATOR, BIOINTEGRATOR PLUS. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Bio Research Institute (Costati, US). The FDA issued a Cleared decision on September 1, 1995 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

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Submission Details

510(k) Number K942769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1994
Decision Date September 01, 1995
Days to Decision 445 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
297d slower than avg
Panel avg: 148d · This submission: 445d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.