Cleared Traditional

K151025 - iHearTest (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K151025 · Ihear Medical, Inc. · Ear, Nose, Throat device
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Dec 2015
Decision
257d
Days
Class 2
Risk

K151025 is an FDA 510(k) clearance for the iHearTest. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Ihear Medical, Inc. (San Leandro, US). The FDA issued a Cleared decision on December 29, 2015 after a review of 257 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - 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: 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 Ihear Medical, Inc. devices

Submission Details

510(k) Number K151025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2015
Decision Date December 29, 2015
Days to Decision 257 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
168d slower than avg
Panel avg: 89d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
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 - EWO Audiometer

All 234
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K151025.
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