Cleared Traditional

K893134 - APACERAM OSSICULAR PROSTHESIS

K893134 is the FDA 510(k) clearance for APACERAM OSSICULAR PROSTHESIS by Asahi Optical Co. C/O Rosati Associates, P.C.. It is a Class 2 Ear, Nose, Throat device (product code ETB) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K893134 · Asahi Optical Co. C/O Rosati Associates, P.C. · Ear, Nose, Throat device
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Aug 1989
Decision
100d
Days
Class 2
Risk

K893134 is an FDA 510(k) clearance for the APACERAM OSSICULAR PROSTHESIS. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Asahi Optical Co. C/O Rosati Associates, P.C. (Birmingham, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 100 days - within the typical 510(k) review window.

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: 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 Asahi Optical Co. C/O Rosati Associates, P.C. devices

Submission Details

510(k) Number K893134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1989
Decision Date August 03, 1989
Days to Decision 100 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 89d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 29
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K893134.
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
XOMED PLATINUM WIRE TEFLON PISTION
K872112 · Xomed, Inc. · Jul 1987
PROSTHESIS WIRE
K870766 · Treace Medical, Inc. · Apr 1987