Cleared Special

K161707 - Madsen Zodiac

K161707 is an FDA 510(k) clearance for Madsen Zodiac, manufactured by Gn Otometrics. The device is a Class 2 Ear, Nose, Throat device with product code ETY cleared through the Special 510(k) pathway after a 72-day FDA review.

K161707 · Gn Otometrics · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
72d
Days
Class 2
Risk

K161707 is an FDA 510(k) clearance for the Madsen Zodiac. Classified as Tester, Auditory Impedance (product code ETY), Class II - Special Controls.

Submitted by Gn Otometrics (Taastrup, DK). The FDA issued a Cleared decision on September 1, 2016 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1090 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gn Otometrics devices

FDA 510(k) Submission Details - K161707

510(k) Number K161707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2016
Decision Date September 01, 2016
Days to Decision 72 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 89d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

ETY Device Classification - Class 2, Special Controls

Product Code ETY Tester, Auditory Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1090
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETY Tester, Auditory Impedance

All 11
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