Cleared Traditional

K972492 - BELL PROSTHESIS (PARTIAL)

K972492 is an FDA 510(k) clearance for BELL PROSTHESIS (PARTIAL), manufactured by Heinz Kurz. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K972492 · Heinz Kurz · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
33d
Days
Class 2
Risk

K972492 is an FDA 510(k) clearance for the BELL PROSTHESIS (PARTIAL). Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Heinz Kurz (Dusslingen, DE). The FDA issued a Cleared decision on August 4, 1997 after a review of 33 days - a notably fast clearance cycle.

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: 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 Heinz Kurz devices

FDA 510(k) Submission Details - K972492

510(k) Number K972492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1997
Decision Date August 04, 1997
Days to Decision 33 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
57d faster than avg
Panel avg: 90d · This submission: 33d
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 K972492.
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
K972815 · Grace Medical, Inc. · Oct 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
K972734 · Mednet Locator, Inc. · Sep 1997
CAUSSE PISTON
K972737 · Mednet Locator, Inc. · Sep 1997
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909 · Xomed, Inc. · Mar 1997
RICHARDS TOTAL/PARTIAL PROSTHESIS
K962564 · Gyrus Ent LLC · Jan 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K964798 · Anthony D. Prescott · Jan 1997