Cleared Traditional

K934107 - BLACK OVAL-TOP TORP/PORP (FDA 510(k) Clearance)

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

K934107 · Smith & Nephew Richards, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
289d
Days
Class 2
Risk

K934107 is an FDA 510(k) clearance for the BLACK OVAL-TOP TORP/PORP. Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Bartlett, US). The FDA issued a Cleared decision on June 8, 1994 after a review of 289 days - an extended review 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: 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K934107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1993
Decision Date June 08, 1994
Days to Decision 289 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
200d slower than avg
Panel avg: 89d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.