Cleared Traditional

TACTICON 1600 (K851441) - FDA 510(k) Clearance

K851441 · Medecon · Ear, Nose, Throat device
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Jun 1985
Decision
78d
Days
-
Risk

K851441 is an FDA 510(k) clearance for the TACTICON 1600. Classified as Hearing Aid, Tactile (product code LRA).

Submitted by Medecon (Cupertino, US). The FDA issued a Cleared decision on June 27, 1985 after a review of 78 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 K851441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1985
Decision Date June 27, 1985
Days to Decision 78 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
11d faster than avg
Panel avg: 89d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRA Hearing Aid, Tactile
Device Class -