Cleared Traditional

Orion (K200529) - FDA 510(k) Clearance

K200529 · Interacoustics A/S · Ear, Nose, Throat device
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Aug 2020
Decision
163d
Days
-
Risk

K200529 is an FDA 510(k) clearance for the Orion. Classified as Apparatus, Vestibular Analysis (product code LXV).

Submitted by Interacoustics A/S (Middelfart, DK). The FDA issued a Cleared decision on August 12, 2020 after a review of 163 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 K200529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2020
Decision Date August 12, 2020
Days to Decision 163 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
74d slower than avg
Panel avg: 89d · This submission: 163d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXV Apparatus, Vestibular Analysis
Device Class -

Regulatory Consultant

Lnteracoustics A/S
Erik Nielsen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.