Cleared Traditional

K121590 - VESTIBULAR ANALYSIS APPARATUS

K121590 · Capacity Sports, LLC · Ear, Nose, Throat device
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Sep 2012
Decision
112d
Days
-
Risk

K121590 is an FDA 510(k) clearance for the VESTIBULAR ANALYSIS APPARATUS. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Capacity Sports, LLC (Pleasant Hill, US). The FDA issued a Cleared decision on September 20, 2012 after a review of 112 days - within the typical 510(k) review window.

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.

View all Capacity Sports, LLC devices

FDA 510(k) Submission Details - K121590

510(k) Number K121590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2012
Decision Date September 20, 2012
Days to Decision 112 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 89d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

LXV Device Classification - Class 0,

Product Code LXV Apparatus, Vestibular Analysis
Device Class -