Cleared Traditional

K864444 - SHEA CUPPED TORP WITH HYDROXYLAPATITE F...

K864444 is an FDA 510(k) clearance for SHEA CUPPED TORP WITH HYDROXYLAPATITE F..., manufactured by Richards Medical Co., Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETA cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K864444 · Richards Medical Co., Inc. · Ear, Nose, Throat device
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Feb 1987
Decision
86d
Days
Class 2
Risk

K864444 is an FDA 510(k) clearance for the SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE. Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 86 days - a notably fast clearance cycle.

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: 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 - K864444

510(k) Number K864444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date February 06, 1987
Days to Decision 86 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
3d faster than avg
Panel avg: 89d · This submission: 86d
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 20
Devices cleared under the same product code (ETA) and FDA review panel - the closest regulatory comparables to K864444.
RICHARDS TORP
K952549 · Smith & Nephew Richards, Inc. · Jul 1995
HAPEX MALLEABLE TORP
K950927 · Smith & Nephew Richards, Inc. · Mar 1995
BLACK OVAL-TOP TORP/PORP
K934107 · Smith & Nephew Richards, Inc. · Jun 1994
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