Cleared Traditional

K121590 - VESTIBULAR ANALYSIS APPARATUS

K121590 · Capacity Sports, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
22d slower than avg
Panel avg: 90d · This submission: 112d
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 14
Devices cleared under the same product code (LXV) and FDA review panel - the closest regulatory comparables to K121590.
ClearEdge Balance System
K183661 · Quadrant Biosciences · Oct 2019
EQ Balance
K190735 · Upright Science, Inc. · Aug 2019
K-D Balance
K173669 · King-Devick Technologies, Inc. · Apr 2018
NYDIAG 200
K102364 · Interacoustics A/S · Dec 2010
VERTIGONE BPPV GOGGLE
K082634 · Vertigone, Inc. · Apr 2009
DIZZYFIX
K081602 · Clearwater Clinical Limited · Sep 2008