Cleared Traditional

TACTAID (K830418) - FDA 510(k) Clearance

K830418 · Audiological Engineering Corp. · Ear, Nose, Throat device
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Mar 1983
Decision
30d
Days
-
Risk

K830418 is an FDA 510(k) clearance for the TACTAID. Classified as Hearing Aid, Tactile (product code LRA).

Submitted by Audiological Engineering Corp.. The FDA issued a Cleared decision on March 10, 1983 after a review of 30 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.

View all Audiological Engineering Corp. devices

Submission Details

510(k) Number K830418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1983
Decision Date March 10, 1983
Days to Decision 30 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
59d faster than avg
Panel avg: 89d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRA Hearing Aid, Tactile
Device Class -