Cleared Traditional

WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER (K862471) - FDA 510(k) Clearance

K862471 · Institute of Logopedics · Ear, Nose, Throat device
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Sep 1986
Decision
74d
Days
-
Risk

K862471 is an FDA 510(k) clearance for the WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER. Classified as Hearing Aid, Tactile (product code LRA).

Submitted by Institute of Logopedics (Attleboro, US). The FDA issued a Cleared decision on September 12, 1986 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel. 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.

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Submission Details

510(k) Number K862471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1986
Decision Date September 12, 1986
Days to Decision 74 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 89d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRA Hearing Aid, Tactile
Device Class -