Cleared Traditional

K843461 - BIOGLASS OSSICULAR RECONSTRUCTION PROSTH

K843461 is an FDA 510(k) clearance for BIOGLASS OSSICULAR RECONSTRUCTION PROSTH, manufactured by American Biomaterials Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ETA cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K843461 · American Biomaterials Corp. · Ear, Nose, Throat device
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Jan 1985
Decision
126d
Days
Class 2
Risk

K843461 is an FDA 510(k) clearance for the BIOGLASS OSSICULAR RECONSTRUCTION PROSTH. Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by American Biomaterials Corp. (Princeton, US). The FDA issued a Cleared decision on January 9, 1985 after a review of 126 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 American Biomaterials Corp. devices

FDA 510(k) Submission Details - K843461

510(k) Number K843461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1984
Decision Date January 09, 1985
Days to Decision 126 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
37d slower than avg
Panel avg: 89d · This submission: 126d
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 K843461.
BLACK OVAL-TOP TORP/PORP
K934107 · Smith & Nephew Richards, Inc. · Jun 1994
SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE
K864444 · Richards Medical Co., Inc. · Feb 1987
EGG-TOP TORP AND EGG-TOP PORP
K864443 · Richards Medical Co., Inc. · Feb 1987
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
K823912 · Treace Medical, Inc. · Jun 1983
PARTIAL OSSICULAR REPLACEMENT
K823917 · Treace Medical, Inc. · Jun 1983
AUSTIN MODIFIED PARTIAL OSSICULAR RE-
K823918 · Treace Medical, Inc. · Jun 1983