Cleared Traditional

K954518 - TREBAY TOTAL RECTANGULAR HEAD

K954518 is an FDA 510(k) clearance for TREBAY TOTAL RECTANGULAR HEAD, manufactured by Trebay Medical Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETA cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K954518 · Trebay Medical Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
29d
Days
Class 2
Risk

K954518 is an FDA 510(k) clearance for the TREBAY TOTAL RECTANGULAR HEAD. Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Trebay Medical Corp. (Clearwater, US). The FDA issued a Cleared decision on October 27, 1995 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3495 - 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 Trebay Medical Corp. devices

FDA 510(k) Submission Details - K954518

510(k) Number K954518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1995
Decision Date October 27, 1995
Days to Decision 29 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
60d faster than avg
Panel avg: 89d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETA Device Classification - Class 2, Special Controls

Product Code ETA Replacement, Ossicular Prosthesis, Total
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3495
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 - ETA Replacement, Ossicular Prosthesis, Total

All 21
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