Cleared Traditional

K173669 - K-D Balance

K173669 · King-Devick Technologies, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
123d
Days
-
Risk

K173669 is an FDA 510(k) clearance for the K-D Balance. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by King-Devick Technologies, Inc. (Oakbrook Terrace, US). The FDA issued a Cleared decision on April 2, 2018 after a review of 123 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.

FDA 510(k) Submission Details - K173669

510(k) Number K173669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2017
Decision Date April 02, 2018
Days to Decision 123 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 90d · This submission: 123d
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 18
Devices cleared under the same product code (LXV) and FDA review panel - the closest regulatory comparables to K173669.
TRV
K192652 · Interacoustics A/S · May 2020
ClearEdge Balance System
K183661 · Quadrant Biosciences · Oct 2019
EQ Balance
K190735 · Upright Science, Inc. · Aug 2019
VESTIBULAR ANALYSIS APPARATUS
K121590 · Capacity Sports, LLC · Sep 2012
NYDIAG 200
K102364 · Interacoustics A/S · Dec 2010
VERTIGONE BPPV GOGGLE
K082634 · Vertigone, Inc. · Apr 2009
K173669 · K-D Balance
Download PDF FDA Summary King-Devick Technolog…