Cleared Traditional

K110286 - GN OTOMETRICS TYPE 1053 FREEFIT

K110286 is an FDA 510(k) clearance for GN OTOMETRICS TYPE 1053 FREEFIT, manufactured by Gn Otometrics A/S. The device is a Class 2 Ear, Nose, Throat device with product code ETW cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K110286 · Gn Otometrics A/S · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
87d
Days
Class 2
Risk

K110286 is an FDA 510(k) clearance for the GN OTOMETRICS TYPE 1053 FREEFIT. Classified as Calibrator, Hearing Aid / Earphone And Analysis Systems (product code ETW), Class II - Special Controls.

Submitted by Gn Otometrics A/S (Schaumburg, US). The FDA issued a Cleared decision on April 28, 2011 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3310 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gn Otometrics A/S devices

FDA 510(k) Submission Details - K110286

510(k) Number K110286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2011
Decision Date April 28, 2011
Days to Decision 87 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 89d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

ETW Device Classification - Class 2, Special Controls

Product Code ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3310
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 - ETW Calibrator, Hearing Aid / Earphone And Analysis Systems

All 10
Devices cleared under the same product code (ETW) and FDA review panel - the closest regulatory comparables to K110286.
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