Cleared Traditional

K891008 - VESTIBULAR OCULAR REFLEX TEST EQUIPMENT...

K891008 · Micromedical Technologies, Inc. · Ear, Nose, Throat device
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May 1989
Decision
89d
Days
-
Risk

K891008 is an FDA 510(k) clearance for the VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ). Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Micromedical Technologies, Inc. (Chatham, US). The FDA issued a Cleared decision on May 31, 1989 after a review of 89 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 K891008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1989
Decision Date May 31, 1989
Days to Decision 89 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
At panel average
Panel avg: 89d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -