Cleared Traditional

K950984 - HAPES MALLEABLE INCUS STAPES

K950984 is the FDA 510(k) clearance for HAPES MALLEABLE INCUS STAPES by Smith & Nephew Richards, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ETB) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K950984 · Smith & Nephew Richards, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
12d
Days
Class 2
Risk

K950984 is an FDA 510(k) clearance for the HAPES MALLEABLE INCUS STAPES. 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 March 15, 1995 after a review of 12 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

Submission Details

510(k) Number K950984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1995
Decision Date March 15, 1995
Days to Decision 12 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
77d faster than avg
Panel avg: 89d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K950984.
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
INCUDOSTAPEDIAL JOINT
K925443 · Smith & Nephew Richards, Inc. · Mar 1993
WEHRS INCUS AND INCUS-STAPES PROSTHESES
K910685 · Smith & Nephew Richards, Inc. · Dec 1991
BUCKET PROSTHESIS PORP
K883727 · Treace Medical, Inc. · Jan 1989