Cleared Traditional

ClearEdge Balance System (K183661) - FDA 510(k) Clearance

K183661 · Quadrant Biosciences · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Oct 2019
Decision
299d
Days
-
Risk

K183661 is an FDA 510(k) clearance for the ClearEdge Balance System. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Quadrant Biosciences (Syracuse, US). The FDA issued a Cleared decision on October 22, 2019 after a review of 299 days - an extended review cycle.

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 K183661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2018
Decision Date October 22, 2019
Days to Decision 299 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
210d slower than avg
Panel avg: 89d · This submission: 299d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -