Cleared Traditional

K922037 - SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR

K922037 · Micromedical Technologies, Inc. · Ear, Nose, Throat device
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Oct 1992
Decision
178d
Days
-
Risk

K922037 is an FDA 510(k) clearance for the SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Micromedical Technologies, Inc. (Chatham, US). The FDA issued a Cleared decision on October 26, 1992 after a review of 178 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K922037

510(k) Number K922037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1992
Decision Date October 26, 1992
Days to Decision 178 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 90d · This submission: 178d
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 K922037.
KOREBALANCE (KINESTHETIC ABILITY TRAINER)
K070676 · Sportkat, LLC · Apr 2007
BALANCE REHABILITATION UNIT (BRU)
K070085 · Medicaa (Uruguay) S.A. · Feb 2007
VMT SYSTEM
K971549 · Target Health, Inc. · Oct 1998
KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000)
K911795 · Breg, Inc. · Nov 1991
VESTIBULAR OCULAR REFLEX TEST EQUIPMENT(VORTEQ)
K891008 · Micromedical Technologies, Inc. · May 1989
BALANCE SYSTEM
K884926 · Chattanooga Group, Inc. · Feb 1989
K922037 · SYSTEM 2000, ROTATIONAL VESTIBULAR CHAIR
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