Cleared Traditional

K972734 - PARTIAL OSSICULAR REPLACEMENT PROSTHESI...

K972734 is an FDA 510(k) clearance for PARTIAL OSSICULAR REPLACEMENT PROSTHESI..., manufactured by Mednet Locator, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K972734 · Mednet Locator, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
45d
Days
Class 2
Risk

K972734 is an FDA 510(k) clearance for the PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP). Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Mednet Locator, Inc. (Memphis, US). The FDA issued a Cleared decision on September 5, 1997 after a review of 45 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 Mednet Locator, Inc. devices

FDA 510(k) Submission Details - K972734

510(k) Number K972734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1997
Decision Date September 05, 1997
Days to Decision 45 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
44d faster than avg
Panel avg: 89d · This submission: 45d
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 K972734.
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K993234 · Micromedics, Inc. · Nov 1999
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
K981045 · Exmoor Plastics , Ltd. · May 1998
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