Cleared Traditional

K952549 - RICHARDS TORP

K952549 is the FDA 510(k) clearance for RICHARDS TORP by Smith & Nephew Richards, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETA) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K952549 · Smith & Nephew Richards, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
31d
Days
Class 2
Risk

K952549 is an FDA 510(k) clearance for the RICHARDS TORP. Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Bartlett, US). The FDA issued a Cleared decision on July 3, 1995 after a review of 31 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K952549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1995
Decision Date July 03, 1995
Days to Decision 31 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 89d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K952549.
BOJRAB MICRO-TORP, MODEL 7014-5845
K990601 · Gyrus Ent LLC · Mar 1999
MILLS COLUMELLA PROSTHESIS
K981088 · Exmoor Plastics , Ltd. · Jun 1998
CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
K963899 · Exmoor Plastics , Ltd. · Aug 1997
HAPEX MALLEABLE TORP
K950927 · Smith & Nephew Richards, Inc. · Mar 1995
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