Cleared Traditional

K964909 - ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS

K964909 is an FDA 510(k) clearance for ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE..., manufactured by Xomed, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K964909 · Xomed, Inc. · Ear, Nose, Throat device
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Mar 1997
Decision
91d
Days
Class 2
Risk

K964909 is an FDA 510(k) clearance for the ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 10, 1997 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3450 - 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 Xomed, Inc. devices

FDA 510(k) Submission Details - K964909

510(k) Number K964909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1996
Decision Date March 10, 1997
Days to Decision 91 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 90d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETB Device Classification - Class 2, Special Controls

Product Code ETB Prosthesis, Partial Ossicular Replacement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3450
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 - ETB Prosthesis, Partial Ossicular Replacement

All 54
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K964909.
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
K972734 · Mednet Locator, Inc. · Sep 1997
CAUSSE PISTON
K972737 · Mednet Locator, Inc. · Sep 1997
BELL PROSTHESIS (PARTIAL)
K972492 · Heinz Kurz · Aug 1997
RICHARDS TOTAL/PARTIAL PROSTHESIS
K962564 · Gyrus Ent LLC · Jan 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K964798 · Anthony D. Prescott · Jan 1997
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
K963752 · Grace Medical, Inc. · Oct 1996