Cleared Traditional

K001142 - AUDIO TECHNOLOGIES S:R.1

K001142 is an FDA 510(k) clearance for AUDIO TECHNOLOGIES S:R.1, manufactured by Audio Technologies S.R.L.. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K001142 · Audio Technologies S.R.L. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
74d
Days
Class 2
Risk

K001142 is an FDA 510(k) clearance for the AUDIO TECHNOLOGIES S:R.1. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Audio Technologies S.R.L. (Piacenza, IT). The FDA issued a Cleared decision on June 23, 2000 after a review of 74 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 Audio Technologies S.R.L. devices

FDA 510(k) Submission Details - K001142

510(k) Number K001142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date June 23, 2000
Days to Decision 74 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
15d faster than avg
Panel avg: 89d · This submission: 74d
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 K001142.
SMITH & NEPHEW PORPS & TORPS
K002737 · Gyrus Ent LLC · Oct 2000
TITANIUM MIDDLE EAR PROSTHESES
K002897 · Xomed, Inc. · Oct 2000
SMITH & NEPHEW OFF-CENTERED PORP
K002464 · Gyrus Ent LLC · Aug 2000
WEHRS INCUS-STAPES
K000858 · Gyrus Ent LLC · Apr 2000
CAP PORP, CAP TORP
K000256 · Gyrus Ent LLC · Feb 2000
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K993234 · Micromedics, Inc. · Nov 1999