Cleared Traditional

BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS (K942651) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K942651 · Casa Futura Technologies · Ear, Nose, Throat device
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Oct 1995
Decision
503d
Days
Class 1
Risk

K942651 is an FDA 510(k) clearance for the BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS. Classified as Device, Anti-stammering (product code KTH), Class I - General Controls.

Submitted by Casa Futura Technologies (Monte Sereno, US). The FDA issued a Cleared decision on October 19, 1995 after a review of 503 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5840 - the FDA ear, nose and throat 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 Ear, Nose, Throat submissions.

View all Casa Futura Technologies devices

Submission Details

510(k) Number K942651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1994
Decision Date October 19, 1995
Days to Decision 503 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
414d slower than avg
Panel avg: 89d · This submission: 503d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KTH Device, Anti-stammering
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5840
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.