Cleared Traditional

EQ Balance (K190735) - FDA 510(k) Clearance

K190735 · Upright Science, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Aug 2019
Decision
148d
Days
-
Risk

K190735 is an FDA 510(k) clearance for the EQ Balance. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Upright Science, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on August 16, 2019 after a review of 148 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 K190735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2019
Decision Date August 16, 2019
Days to Decision 148 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
59d slower than avg
Panel avg: 89d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -