Cleared Traditional

K891008 - VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)

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.

FDA 510(k) Submission Details - K891008

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 90d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

LXV Device Classification - Class 0,

Product Code LXV Apparatus, Vestibular Analysis
Device Class -

Regulatory Peers - LXV Apparatus, Vestibular Analysis

All 21
Devices cleared under the same product code (LXV) and FDA review panel - the closest regulatory comparables to K891008.
VMT SYSTEM
K971549 · Target Health, Inc. · Oct 1998
SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR
K922037 · Micromedical Technologies, Inc. · Oct 1992
KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)
K911795 · Breg, Inc. · Nov 1991
BALANCE SYSTEM
K884926 · Chattanooga Group, Inc. · Feb 1989
RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING
K872093 · Ics Medical Corp. · Sep 1987
EQUITEST
K851744 · Neurocom International, Inc. · Aug 1985
K891008 · VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)
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