Cleared Traditional

K861369 - INCUS/STAPES PROSTHESIS

K861369 is an FDA 510(k) clearance for INCUS/STAPES PROSTHESIS, manufactured by Richards Medical Co., Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K861369 · Richards Medical Co., Inc. · Ear, Nose, Throat device
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Jul 1986
Decision
94d
Days
Class 2
Risk

K861369 is an FDA 510(k) clearance for the INCUS/STAPES PROSTHESIS. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on July 14, 1986 after a review of 94 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K861369

510(k) Number K861369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1986
Decision Date July 14, 1986
Days to Decision 94 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 89d · This submission: 94d
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 K861369.
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
MICROTEK STAINLESS STEEL PISTON
K860460 · Microtek Medical, Inc. · Jul 1986
INCUS PROSTHESIS
K844961 · Richards Medical Co., Inc. · Feb 1985
CAUSSE SPONGE BOAT
K841353 · Treace Medical, Inc. · Jul 1984