Cleared Traditional

K945104 - MICROMED PARTIAL REGULAR AND PARTIAL OFFSET

K945104 is an FDA 510(k) clearance for MICROMED PARTIAL REGULAR AND PARTIAL OFFSET, manufactured by Micromed Development Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K945104 · Micromed Development Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
35d
Days
Class 2
Risk

K945104 is an FDA 510(k) clearance for the MICROMED PARTIAL REGULAR AND PARTIAL OFFSET. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Micromed Development Corp. (Clearwater, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 35 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 Micromed Development Corp. devices

FDA 510(k) Submission Details - K945104

510(k) Number K945104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1994
Decision Date November 22, 1994
Days to Decision 35 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 89d · This submission: 35d
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 K945104.
HAPEX PORP
K950886 · Smith & Nephew Richards, Inc. · Mar 1995
HAPEX INCUS
K950887 · Smith & Nephew Richards, Inc. · Mar 1995
HAPES MALLEABLE INCUS STAPES
K950984 · Smith & Nephew Richards, Inc. · Mar 1995
INCUDOSTAPEDIAL JOINT
K925443 · Smith & Nephew Richards, Inc. · Mar 1993
WEHRS INCUS AND INCUS-STAPES PROSTHESES
K910685 · Smith & Nephew Richards, Inc. · Dec 1991
BUCKET PROSTHESIS PORP
K883727 · Treace Medical, Inc. · Jan 1989