Cleared Traditional

K102364 - NYDIAG 200

K102364 · Interacoustics A/S · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
125d
Days
-
Risk

K102364 is an FDA 510(k) clearance for the NYDIAG 200. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Interacoustics A/S (Assens, DK). The FDA issued a Cleared decision on December 23, 2010 after a review of 125 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 - K102364

510(k) Number K102364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2010
Decision Date December 23, 2010
Days to Decision 125 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
35d slower than avg
Panel avg: 90d · This submission: 125d
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 K102364.
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EPLEY OMNIAX
K071973 · Vesticon · Jun 2008
K102364 · NYDIAG 200
Download PDF FDA Summary Interacoustics A/S