Cleared Traditional

TRV (K192652) - FDA 510(k) Clearance

K192652 · Interacoustics A/S · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
May 2020
Decision
246d
Days
-
Risk

K192652 is an FDA 510(k) clearance for the TRV. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Interacoustics A/S (Middelfart, DK). The FDA issued a Cleared decision on May 27, 2020 after a review of 246 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.

View all Interacoustics A/S devices

Submission Details

510(k) Number K192652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2019
Decision Date May 27, 2020
Days to Decision 246 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
157d slower than avg
Panel avg: 89d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -