Cleared Traditional

K952481 - RICHARDS PORP

K952481 is an FDA 510(k) clearance for RICHARDS PORP, manufactured by Smith & Nephew Richards, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K952481 · Smith & Nephew Richards, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
17d
Days
Class 2
Risk

K952481 is an FDA 510(k) clearance for the RICHARDS PORP. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Bartlett, US). The FDA issued a Cleared decision on June 16, 1995 after a review of 17 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 Smith & Nephew Richards, Inc. devices

FDA 510(k) Submission Details - K952481

510(k) Number K952481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1995
Decision Date June 16, 1995
Days to Decision 17 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
73d faster than avg
Panel avg: 90d · This submission: 17d
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 54
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K952481.
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K964798 · Anthony D. Prescott · Jan 1997
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
K963752 · Grace Medical, Inc. · Oct 1996
POLY/PLATINUM WIRE PISTON
K945105 · Micromed Development Corp. · May 1996
HAPEX MALLEABLE PORP
K950885 · Smith & Nephew Richards, Inc. · Mar 1995
HAPEX PORP
K950886 · Smith & Nephew Richards, Inc. · Mar 1995
HAPEX INCUS
K950887 · Smith & Nephew Richards, Inc. · Mar 1995