Cleared Traditional

CHAIR, VESTIBULAR, ROTARY, COMPUT. (K781268) - FDA 510(k) Clearance

K781268 · Contraves · Ear, Nose, Throat device
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Aug 1978
Decision
21d
Days
-
Risk

K781268 is an FDA 510(k) clearance for the CHAIR, VESTIBULAR, ROTARY, COMPUT.. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Contraves (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 21 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 K781268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1978
Decision Date August 14, 1978
Days to Decision 21 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
68d faster than avg
Panel avg: 89d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -