Cleared Traditional

APACERAM OSSICULAR PROSTHESIS (K893134) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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 73
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K893134.
mGRIP Partial Prosthesis (0.75 mm) (58669)
K260718 · Med-El Elektromedizinische Ger?te GmbH · Apr 2026
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717)
K260720 · Med-El Elektromedizinische Ger?te GmbH · Apr 2026
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
K241142 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
K241261 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025