Cleared Traditional

K173669 - K-D Balance (FDA 510(k) Clearance)

K173669 · King-Devick Technologies, Inc. · Ear, Nose, Throat device
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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.

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Submission Details

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
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 89d · This submission: 123d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -