Cleared Traditional

K001404 - GOLD TOTAL AND PARTIAL

K001404 is an FDA 510(k) clearance for GOLD TOTAL AND PARTIAL, manufactured by Mednet Locator, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETA cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K001404 · Mednet Locator, Inc. · Ear, Nose, Throat device
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Aug 2000
Decision
97d
Days
Class 2
Risk

K001404 is an FDA 510(k) clearance for the GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES,.... Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Mednet Locator, Inc. (Memphis, US). The FDA issued a Cleared decision on August 8, 2000 after a review of 97 days - within the typical 510(k) review window.

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 Mednet Locator, Inc. devices

FDA 510(k) Submission Details - K001404

510(k) Number K001404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2000
Decision Date August 08, 2000
Days to Decision 97 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
8d slower than avg
Panel avg: 89d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ETA Replacement, Ossicular Prosthesis, Total

All 21
Devices cleared under the same product code (ETA) and FDA review panel - the closest regulatory comparables to K001404.
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
K241269 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
FISCH TITANIUM MIDDLE EAR PROSTHESES
K043375 · Karl Storz Endoscopy · Jan 2005
MODULAR PORP AND TORP MODEL TBD
K002378 · Gyrus Ent LLC · Aug 2000
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
K001902 · Gyrus Ent LLC · Jul 2000
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
K993583 · Stryker Corp. · Nov 1999
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
K992138 · Micromedics, Inc. · Aug 1999