Cleared Traditional

K844961 - INCUS PROSTHESIS

K844961 is an FDA 510(k) clearance for INCUS 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 67-day FDA review.

K844961 · Richards Medical Co., Inc. · Ear, Nose, Throat device
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Feb 1985
Decision
67d
Days
Class 2
Risk

K844961 is an FDA 510(k) clearance for the INCUS 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 February 26, 1985 after a review of 67 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K844961

510(k) Number K844961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1984
Decision Date February 26, 1985
Days to Decision 67 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
22d faster than avg
Panel avg: 89d · This submission: 67d
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 K844961.
PROSTHESIS WIRE
K870766 · Treace Medical, Inc. · Apr 1987
INCUS/STAPES PROSTHESIS
K861369 · Richards Medical Co., Inc. · Jul 1986
MICROTEK STAINLESS STEEL PISTON
K860460 · Microtek Medical, Inc. · Jul 1986
CAUSSE SPONGE BOAT
K841353 · Treace Medical, Inc. · Jul 1984
FISCH MODIFIED TEF-WIRE PISTON
K823429 · Treace Medical, Inc. · Dec 1982
CAUSSE TEF-PISTON
K823439 · Treace Medical, Inc. · Dec 1982