Cleared Traditional

EARCLEAR (K951596) - FDA 510(k) Clearance

K951596 · Arisil Medical · Ear, Nose, Throat device
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May 1995
Decision
47d
Days
-
Risk

K951596 is an FDA 510(k) clearance for the EARCLEAR. Classified as Device, Inflation, Middle Ear within the MJV classification (a niche ENT category for middle ear pressure regulation devices).

Submitted by Arisil Medical (Brooklyn, US). The FDA issued a Cleared decision on May 24, 1995 after a review of 47 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. Middle ear inflation devices represent a low-volume ENT category with limited predicate history - the 165-day review reflects the FDA's careful equivalence assessment for this specialized device type.

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Submission Details

510(k) Number K951596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1995
Decision Date May 24, 1995
Days to Decision 47 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
42d faster than avg
Panel avg: 89d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MJV Device, Inflation, Middle Ear
Device Class -