Cleared Traditional

K964798 - PARTIAL OSSICULAR REPLACEMENT PROSTHESIS

K964798 is an FDA 510(k) clearance for PARTIAL OSSICULAR REPLACEMENT PROSTHESIS, manufactured by Anthony D. Prescott. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K964798 · Anthony D. Prescott · Ear, Nose, Throat device
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Jan 1997
Decision
34d
Days
Class 2
Risk

K964798 is an FDA 510(k) clearance for the PARTIAL OSSICULAR REPLACEMENT PROSTHESIS. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Anthony D. Prescott (Memphis, US). The FDA issued a Cleared decision on January 2, 1997 after a review of 34 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 Anthony D. Prescott devices

FDA 510(k) Submission Details - K964798

510(k) Number K964798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1996
Decision Date January 02, 1997
Days to Decision 34 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
55d faster than avg
Panel avg: 89d · This submission: 34d
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 37
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K964798.
MILLS INCUS HA SLEEVE
K974365 · Exmoor Plastics , Ltd. · Jan 1998
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909 · Xomed, Inc. · Mar 1997
RICHARDS TOTAL/PARTIAL PROSTHESIS
K962564 · Gyrus Ent LLC · Jan 1997
RICHARDS PORP
K952481 · Smith & Nephew Richards, Inc. · Jun 1995
HAPEX MALLEABLE PORP
K950885 · Smith & Nephew Richards, Inc. · Mar 1995
HAPEX PORP
K950886 · Smith & Nephew Richards, Inc. · Mar 1995