Cleared Traditional

K972383 - EASY-JET DEVICE (FDA 510(k) Clearance)

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

K972383 · A.Stein - Regulatory Affairs Consulting · Ear, Nose, Throat device
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Nov 1999
Decision
880d
Days
Class 2
Risk

K972383 is an FDA 510(k) clearance for the EASY-JET DEVICE. Classified as Tube, Shunt, Endolymphatic With Valve (product code KLZ), Class II - Special Controls.

Submitted by A.Stein - Regulatory Affairs Consulting (Ginot Shomron 44853, IL). The FDA issued a Cleared decision on November 23, 1999 after a review of 880 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3850 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ear, Nose, Throat submissions.

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Submission Details

510(k) Number K972383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date November 23, 1999
Days to Decision 880 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
791d slower than avg
Panel avg: 89d · This submission: 880d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLZ Tube, Shunt, Endolymphatic With Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3850
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.